simvastatin

Product NDC: 16729-006
11-digit product format: 167290006
Labeler code: 16729
Product ID: 16729-006_43910ff2-6a21-bf9e-e063-6294a90a3f5c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Accord Healthcare, Inc.
Application: ANDA078155
Marketing category: ANDA
Marketing start: 2008-02-26
Substance: SIMVASTATIN
Active strength: 40 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078155-001	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26
A078155-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26
A078155-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26
A078155-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26
A078155-005	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A078155-001	AB
A078155-002	AB
A078155-003	AB
A078155-004	AB
A078155-005	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078155-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078155-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078155-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078155-005	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: simvastatin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SIMVASTATIN	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
AGG2FN16EV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198211	Internal RxNorm lookup
200345	Internal RxNorm lookup
312961	Internal RxNorm lookup
312962	Internal RxNorm lookup
314231	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
871251c0-36a1-4a32-9eab-ff6c1e925ca9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5347abc9-d72b-9efb-f582-cc87efafcf1b	Product name	4	20250729
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
c4422d73-8e69-1539-606a-32a25fa00ebc	Product name	4	20190926
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6	Product name	1	20160615
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-006-10	simvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30	22
16729-006-12	simvastatin	60 in 1 BOTTLE	TABLET, FILM COATED	60	22
16729-006-15	simvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90	22
16729-006-17	simvastatin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-006-10	EA - Each	16729-006	f02fdbe2-2f0c-485f-8667-f02eaa0790f1	1	2012-07-24
16729-006-15	EA - Each	16729-006	ede33287-7ce7-447b-9196-ce3b838b06f0	1	2012-07-24
16729-006-17	EA - Each	16729-006	4604fbf5-b253-441d-b5be-f57a7eb8e52a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-006	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	21	Current NDC, Legacy NDC, 4 package rows	20240719_871251c0-36a1-4a32-9eab-ff6c1e925ca9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	aa8aed58-691b-472e-8e98-53d0d3f56686	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	7463b093-c2ee-49c3-a08a-e758de66422a	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	c6b610ab-7367-4e61-9b4a-7ebbd1cf3d36	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	c03ab80c-a3ae-4634-a76b-f53740db76f5	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Northwind Health Company, LLC	db0f4c5a-e8e4-3ab1-e053-2995a90a1f9a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f32d512f-86fa-b70f-e053-2a95a90afd01	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	QPharma, Inc.	c80b823c-b30f-0a9d-e053-2995a90a31e9	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Accord Healthcare, Inc.	871251c0-36a1-4a32-9eab-ff6c1e925ca9	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155 ndc (product): 16729-006
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	56456210-2db5-4f0d-e054-00144ff8d46c	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	b6d5fb21-a1a8-53e5-80d9-dde0eede5ef5	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	356ed6a6-e467-4791-87ff-2ae7779fc1b0	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	ce3ac5e8-bdef-d195-e0a0-e1a982008efe	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	79ca09cd-2396-4e50-b159-1f9567115067	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	54c236ce-69c2-06ef-e054-00144ff88e88	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	54c28733-eb99-10f6-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	8ed46bb1-9f84-4418-e053-2a95a90abd4b	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	8e986df7-3020-6755-e053-2995a90aca37	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	A-S Medication Solutions	aaeebbc3-2608-41b5-8420-5a2a80316d39	2023-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Proficient Rx LP	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	b5bebcd0-84e6-410d-af96-63834d262bad	2021-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AGG2FN16EV	SIMVASTATIN	79902-63-9	SIMVASTATIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198211	simvastatin 40 MG Oral Tablet	PSN	356ed6a6-e467-4791-87ff-2ae7779fc1b0	1019
198211	simvastatin 40 MG Oral Tablet	SCD	356ed6a6-e467-4791-87ff-2ae7779fc1b0	1019
198211	simvastatin 40 MG Oral Tablet	PSN	7463b093-c2ee-49c3-a08a-e758de66422a	29
198211	simvastatin 40 MG Oral Tablet	SCD	7463b093-c2ee-49c3-a08a-e758de66422a	29
314231	simvastatin 10 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
312961	simvastatin 20 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
198211	simvastatin 40 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
312962	simvastatin 5 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
200345	simvastatin 80 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
314231	simvastatin 10 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
312961	simvastatin 20 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
198211	simvastatin 40 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
312962	simvastatin 5 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
200345	simvastatin 80 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
314231	simvastatin 10 MG Oral Tablet	PSN	e92b873a-0ccc-4852-845b-e27e5daab40e	13
314231	simvastatin 10 MG Oral Tablet	PSN	f2a20844-9918-40f6-be69-6dea54b877a7	13
312961	simvastatin 20 MG Oral Tablet	PSN	f2a20844-9918-40f6-be69-6dea54b877a7	13
198211	simvastatin 40 MG Oral Tablet	PSN	e92b873a-0ccc-4852-845b-e27e5daab40e	13
198211	simvastatin 40 MG Oral Tablet	PSN	f2a20844-9918-40f6-be69-6dea54b877a7	13
200345	simvastatin 80 MG Oral Tablet	PSN	e92b873a-0ccc-4852-845b-e27e5daab40e	13
314231	simvastatin 10 MG Oral Tablet	SCD	f2a20844-9918-40f6-be69-6dea54b877a7	13
314231	simvastatin 10 MG Oral Tablet	SCD	e92b873a-0ccc-4852-845b-e27e5daab40e	13
312961	simvastatin 20 MG Oral Tablet	SCD	f2a20844-9918-40f6-be69-6dea54b877a7	13
198211	simvastatin 40 MG Oral Tablet	SCD	f2a20844-9918-40f6-be69-6dea54b877a7	13
198211	simvastatin 40 MG Oral Tablet	SCD	e92b873a-0ccc-4852-845b-e27e5daab40e	13
200345	simvastatin 80 MG Oral Tablet	SCD	e92b873a-0ccc-4852-845b-e27e5daab40e	13
312961	simvastatin 20 MG Oral Tablet	PSN	e3a08f36-d80a-40e2-8572-d9b991b60c0d	11
198211	simvastatin 40 MG Oral Tablet	PSN	e3a08f36-d80a-40e2-8572-d9b991b60c0d	11
312961	simvastatin 20 MG Oral Tablet	SCD	e3a08f36-d80a-40e2-8572-d9b991b60c0d	11
198211	simvastatin 40 MG Oral Tablet	SCD	e3a08f36-d80a-40e2-8572-d9b991b60c0d	11
314231	simvastatin 10 MG Oral Tablet	PSN	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	8
312961	simvastatin 20 MG Oral Tablet	PSN	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	8
198211	simvastatin 40 MG Oral Tablet	PSN	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	8
314231	simvastatin 10 MG Oral Tablet	SCD	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	8
312961	simvastatin 20 MG Oral Tablet	SCD	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	8
198211	simvastatin 40 MG Oral Tablet	SCD	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	8
198211	simvastatin 40 MG Oral Tablet	PSN	54c236ce-69c2-06ef-e054-00144ff88e88	5
198211	simvastatin 40 MG Oral Tablet	SCD	54c236ce-69c2-06ef-e054-00144ff88e88	5
198211	simvastatin 40 MG Oral Tablet	PSN	9d0952e5-1172-4ef2-9c99-d2b3f8bace59	4
198211	simvastatin 40 MG Oral Tablet	PSN	f32d512f-86fa-b70f-e053-2a95a90afd01	4
198211	simvastatin 40 MG Oral Tablet	SCD	9d0952e5-1172-4ef2-9c99-d2b3f8bace59	4
198211	simvastatin 40 MG Oral Tablet	SCD	f32d512f-86fa-b70f-e053-2a95a90afd01	4
198211	simvastatin 40 MG Oral Tablet	PSN	48bc36db-f3c2-460a-8d11-13e5c576efeb	3
198211	simvastatin 40 MG Oral Tablet	PSN	8e986df7-3020-6755-e053-2995a90aca37	3
198211	simvastatin 40 MG Oral Tablet	SCD	8e986df7-3020-6755-e053-2995a90aca37	3
198211	simvastatin 40 MG Oral Tablet	SCD	48bc36db-f3c2-460a-8d11-13e5c576efeb	3
312961	simvastatin 20 MG Oral Tablet	PSN	597c10d1-76fb-1408-e053-2991aa0a78d2	2
312961	simvastatin 20 MG Oral Tablet	PSN	6fcd7ba3-02cd-41e9-85d5-494961155d3e	2
198211	simvastatin 40 MG Oral Tablet	PSN	b5bebcd0-84e6-410d-af96-63834d262bad	2
198211	simvastatin 40 MG Oral Tablet	PSN	6fcd7ba3-02cd-41e9-85d5-494961155d3e	2
198211	simvastatin 40 MG Oral Tablet	PSN	597c10d1-76fb-1408-e053-2991aa0a78d2	2
312961	simvastatin 20 MG Oral Tablet	SCD	6fcd7ba3-02cd-41e9-85d5-494961155d3e	2
312961	simvastatin 20 MG Oral Tablet	SCD	597c10d1-76fb-1408-e053-2991aa0a78d2	2
198211	simvastatin 40 MG Oral Tablet	SCD	6fcd7ba3-02cd-41e9-85d5-494961155d3e	2
198211	simvastatin 40 MG Oral Tablet	SCD	597c10d1-76fb-1408-e053-2991aa0a78d2	2
198211	simvastatin 40 MG Oral Tablet	SCD	b5bebcd0-84e6-410d-af96-63834d262bad	2
314231	simvastatin 10 MG Oral Tablet	PSN	0f878e82-7ce1-450b-abb0-2090c22b389b	1
314231	simvastatin 10 MG Oral Tablet	PSN	ef3c6f57-2729-4e32-8e7f-cd91d0cb713f	1
314231	simvastatin 10 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
312961	simvastatin 20 MG Oral Tablet	PSN	0f878e82-7ce1-450b-abb0-2090c22b389b	1
312961	simvastatin 20 MG Oral Tablet	PSN	ef3c6f57-2729-4e32-8e7f-cd91d0cb713f	1
312961	simvastatin 20 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
198211	simvastatin 40 MG Oral Tablet	PSN	ef3c6f57-2729-4e32-8e7f-cd91d0cb713f	1
198211	simvastatin 40 MG Oral Tablet	PSN	0f878e82-7ce1-450b-abb0-2090c22b389b	1
198211	simvastatin 40 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
198211	simvastatin 40 MG Oral Tablet	PSN	a3b22473-c221-43ad-98ec-3106e297cb83	1
200345	simvastatin 80 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
314231	simvastatin 10 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
314231	simvastatin 10 MG Oral Tablet	SCD	ef3c6f57-2729-4e32-8e7f-cd91d0cb713f	1
314231	simvastatin 10 MG Oral Tablet	SCD	0f878e82-7ce1-450b-abb0-2090c22b389b	1
312961	simvastatin 20 MG Oral Tablet	SCD	ef3c6f57-2729-4e32-8e7f-cd91d0cb713f	1
312961	simvastatin 20 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
312961	simvastatin 20 MG Oral Tablet	SCD	0f878e82-7ce1-450b-abb0-2090c22b389b	1
198211	simvastatin 40 MG Oral Tablet	SCD	ef3c6f57-2729-4e32-8e7f-cd91d0cb713f	1
198211	simvastatin 40 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
198211	simvastatin 40 MG Oral Tablet	SCD	0f878e82-7ce1-450b-abb0-2090c22b389b	1
198211	simvastatin 40 MG Oral Tablet	SCD	a3b22473-c221-43ad-98ec-3106e297cb83	1
200345	simvastatin 80 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-006-10	16729000610	30 TABLET, FILM COATED in 1 BOTTLE (16729-006-10)	2008-02-26	0000-00-00	No	No	Current
16729-006-12	16729000612	60 in 1 BOTTLE					Historical
16729-006-15	16729000615	90 TABLET, FILM COATED in 1 BOTTLE (16729-006-15)	2008-02-26	0000-00-00	No	No	Current
16729-006-17	16729000617	1000 TABLET, FILM COATED in 1 BOTTLE (16729-006-17)	2008-02-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
simvastatin	PD-Rx Pharmaceuticals, Inc.	2026-05-12	HUMAN PRESCRIPTION DRUG LABEL	29
simvastatin	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
simvastatin	Accord Healthcare, Inc. \| Intas Pharmaceuticals Limited.	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL	22
SIMVASTATIN	St Marys Medical Park Pharmacy	2024-12-11	HUMAN PRESCRIPTION DRUG LABEL	11
simvastatin	Preferred Pharmaceuticals, Inc.	2024-08-09	HUMAN PRESCRIPTION DRUG LABEL	13
simvastatin	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	1019
simvastatin	REMEDYREPACK INC.	2024-07-26	HUMAN PRESCRIPTION DRUG LABEL	14
simvastatin	NuCare Pharmaceuticals,Inc. \| NuCare Pharmaceuticals Inc..	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	5
simvastatin	NuCare Pharmaceuticals,Inc.	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL	3
simvastatin	A-S Medication Solutions	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	34
simvastatin	REMEDYREPACK INC.	2023-08-08	HUMAN PRESCRIPTION DRUG LABEL	8
simvastatin	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	13
SIMVASTATIN	DIRECT RX	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	13
simvastatin	Proficient Rx LP	2022-05-01	HUMAN PRESCRIPTION DRUG LABEL	8
simvastatin	A-S Medication Solutions	2021-05-18	HUMAN PRESCRIPTION DRUG LABEL	1
simvastatin	Aphena Pharma Solutions - Tennessee, LLC	2021-04-27	HUMAN PRESCRIPTION DRUG LABEL	2
simvastatin	NuCare Pharmaceuticals, Inc.	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	3
simvastatin	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	3
simvastatin	Bryant Ranch Prepack	2020-07-07	HUMAN PRESCRIPTION DRUG LABEL	1
simvastatin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-06-17	HUMAN PRESCRIPTION DRUG LABEL	1
simvastatin	NuCare Pharmaceuticals,Inc.	2019-08-19	HUMAN PRESCRIPTION DRUG LABEL	1
simvastatin	Contract Pharmacy Services-PA \| Coupler Enterprises	2018-12-29	HUMAN PRESCRIPTION DRUG LABEL	2
simvastatin	KAISER FOUNDATION HOSPITALS	2018-11-19	HUMAN PRESCRIPTION DRUG LABEL	3