SIMVASTATIN

Product NDC: 68180-464
11-digit product format: 681800464
Labeler code: 68180
Product ID: 68180-464_b78d4e8a-2261-43c6-9321-ac2539bdfd2f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SIMVASTATIN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA078103
Marketing category: ANDA
Marketing start: 2016-02-19
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
A078103-001	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11
A078103-002	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11
A078103-003	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11
A078103-004	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11
A078103-005	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078103-001	AB
A078103-002	AB
A078103-003	AB
A078103-004	AB
A078103-005	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 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078103-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078103-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078103-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078103-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078103-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078103-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078103-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078103-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078103-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078103-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078103-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078103-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: SIMVASTATIN
Listing expiration: 2027-12-31

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
3e48217f-8175-4e9b-9fd0-909be4bbba95	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
68180-464-03	SIMVASTATIN	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	23
68180-464-06	SIMVASTATIN	30 in 1 BOTTLE	TABLET, FILM COATED	30	23
68180-464-09	SIMVASTATIN	90 in 1 BOTTLE	TABLET, FILM COATED	90	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-464-03	EA - Each	68180-464	0821ffcb-457f-433a-adb6-91da3eefef55	1	2016-03-04
68180-464-06	EA - Each	68180-464	a80faa53-6fb3-4182-a295-efe33d81bf27	1	2016-09-02
68180-464-09	EA - Each	68180-464	a128eb07-9252-486c-85d8-9d52b99b7966	1	2016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-464	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	21	Current NDC, Legacy NDC, 3 package rows	20250515_3e48217f-8175-4e9b-9fd0-909be4bbba95.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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	e447cc46-adee-4126-8b85-f00f81a6e93c	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	St. Mary's Medical Park Pharmacy	f94d5907-737e-df67-e053-6394a90a82a6	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	St. Mary's Medical Park Pharmacy	faa81817-3ffa-b83c-e053-6294a90a3f85	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	St. Mary's Medical Park Pharmacy	f94e5e28-f0b1-700a-e053-6394a90adb7b	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Coupler LLC	5257271e-5c07-4996-e063-6394a90a4424	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Coupler LLC	52573b98-6e51-9753-e063-6294a90ac8c4	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	5ae78a86-ccca-4714-b77e-7bc885b674b5	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	QPharma, Inc	f71fc0ac-223e-18c1-e053-6394a90a45ca	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Coupler LLC	50733b85-067d-99c3-e063-6394a90a4244	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	5c760852-800b-463e-8059-06a9a82c2225	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	7abc03f8-9d5f-4f7d-9e32-fc463ec0597c	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	e59bf31f-d880-4d9e-b6c2-5a18a53718f9	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	e4d8ebf3-7f9f-4725-a104-1d1bf6e6f768	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	0ccb324f-877d-4f32-a769-7cd1637b7fad	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	00896fff-081d-4553-be8c-1999a8a73dda	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	143bf1d6-11c5-4a1f-b106-844e0435ee13	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	25d9f841-31d8-4514-ac73-ffe138ff69c7	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	aaca7284-d2d8-42e3-b153-ddc3d2ce907c	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	76ea62f3-4efb-4649-829d-3f0c28d5dae7	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	d099d003-4c7c-4e35-ad6e-94ddf20035b7	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103

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	7abc03f8-9d5f-4f7d-9e32-fc463ec0597c	103
198211	simvastatin 40 MG Oral Tablet	SCD	7abc03f8-9d5f-4f7d-9e32-fc463ec0597c	103
314231	simvastatin 10 MG Oral Tablet	PSN	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
312961	simvastatin 20 MG Oral Tablet	PSN	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
198211	simvastatin 40 MG Oral Tablet	PSN	00896fff-081d-4553-be8c-1999a8a73dda	23
198211	simvastatin 40 MG Oral Tablet	PSN	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
312962	simvastatin 5 MG Oral Tablet	PSN	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
200345	simvastatin 80 MG Oral Tablet	PSN	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
314231	simvastatin 10 MG Oral Tablet	SCD	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
312961	simvastatin 20 MG Oral Tablet	SCD	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
198211	simvastatin 40 MG Oral Tablet	SCD	00896fff-081d-4553-be8c-1999a8a73dda	23
198211	simvastatin 40 MG Oral Tablet	SCD	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
312962	simvastatin 5 MG Oral Tablet	SCD	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
200345	simvastatin 80 MG Oral Tablet	SCD	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
198211	simvastatin 40 MG Oral Tablet	PSN	3b0720d2-b240-48e4-af77-9ccda509fae7	12
198211	simvastatin 40 MG Oral Tablet	SCD	3b0720d2-b240-48e4-af77-9ccda509fae7	12
198211	simvastatin 40 MG Oral Tablet	PSN	51dd8d34-e660-49dc-a86e-07d031a18465	11
198211	simvastatin 40 MG Oral Tablet	SCD	51dd8d34-e660-49dc-a86e-07d031a18465	11
198211	simvastatin 40 MG Oral Tablet	PSN	e59bf31f-d880-4d9e-b6c2-5a18a53718f9	10
198211	simvastatin 40 MG Oral Tablet	SCD	e59bf31f-d880-4d9e-b6c2-5a18a53718f9	10
198211	simvastatin 40 MG Oral Tablet	PSN	d099d003-4c7c-4e35-ad6e-94ddf20035b7	9
198211	simvastatin 40 MG Oral Tablet	SCD	d099d003-4c7c-4e35-ad6e-94ddf20035b7	9
198211	simvastatin 40 MG Oral Tablet	PSN	8850724a-a431-46e5-b88e-1d77b0b62d6e	7
198211	simvastatin 40 MG Oral Tablet	SCD	8850724a-a431-46e5-b88e-1d77b0b62d6e	7
314231	simvastatin 10 MG Oral Tablet	PSN	0901f56b-07dd-4e33-a13d-2a047d5c5f5b	4
312961	simvastatin 20 MG Oral Tablet	PSN	0901f56b-07dd-4e33-a13d-2a047d5c5f5b	4
198211	simvastatin 40 MG Oral Tablet	PSN	7649bec7-04c6-47b5-a050-15923006dac0	4
198211	simvastatin 40 MG Oral Tablet	PSN	f71f71db-e0dd-6609-e053-6294a90a4450	4
198211	simvastatin 40 MG Oral Tablet	PSN	0901f56b-07dd-4e33-a13d-2a047d5c5f5b	4
314231	simvastatin 10 MG Oral Tablet	SCD	0901f56b-07dd-4e33-a13d-2a047d5c5f5b	4
312961	simvastatin 20 MG Oral Tablet	SCD	0901f56b-07dd-4e33-a13d-2a047d5c5f5b	4
198211	simvastatin 40 MG Oral Tablet	SCD	7649bec7-04c6-47b5-a050-15923006dac0	4
198211	simvastatin 40 MG Oral Tablet	SCD	f71f71db-e0dd-6609-e053-6294a90a4450	4
198211	simvastatin 40 MG Oral Tablet	SCD	0901f56b-07dd-4e33-a13d-2a047d5c5f5b	4
198211	simvastatin 40 MG Oral Tablet	PSN	f94d5907-737e-df67-e053-6394a90a82a6	3
198211	simvastatin 40 MG Oral Tablet	PSN	f835af8f-7d84-1978-e053-6294a90a22ae	3
198211	simvastatin 40 MG Oral Tablet	PSN	f5dd1835-6d40-40da-e053-2a95a90ad121	3
198211	simvastatin 40 MG Oral Tablet	SCD	f94d5907-737e-df67-e053-6394a90a82a6	3
198211	simvastatin 40 MG Oral Tablet	SCD	f835af8f-7d84-1978-e053-6294a90a22ae	3
198211	simvastatin 40 MG Oral Tablet	SCD	f5dd1835-6d40-40da-e053-2a95a90ad121	3
198211	simvastatin 40 MG Oral Tablet	PSN	06703194-b41a-2bbe-e063-6394a90ac41f	2
198211	simvastatin 40 MG Oral Tablet	SCD	06703194-b41a-2bbe-e063-6394a90ac41f	2
198211	simvastatin 40 MG Oral Tablet	PSN	f2f67ab8-49a1-23df-e053-2a95a90a4050	1
198211	simvastatin 40 MG Oral Tablet	PSN	adf42271-76c0-0fd2-e053-2995a90af7eb	1
198211	simvastatin 40 MG Oral Tablet	PSN	52573b98-6e51-9753-e063-6294a90ac8c4	1
198211	simvastatin 40 MG Oral Tablet	SCD	f2f67ab8-49a1-23df-e053-2a95a90a4050	1
198211	simvastatin 40 MG Oral Tablet	SCD	adf42271-76c0-0fd2-e053-2995a90af7eb	1
198211	simvastatin 40 MG Oral Tablet	SCD	52573b98-6e51-9753-e063-6294a90ac8c4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-464-03	68180046403	1000 TABLET, FILM COATED in 1 BOTTLE (68180-464-03)	2016-02-19	0000-00-00	No	No	Current
68180-464-06	68180046406	30 TABLET, FILM COATED in 1 BOTTLE (68180-464-06)	2016-07-29	0000-00-00	No	No	Current
68180-464-09	68180046409	90 TABLET, FILM COATED in 1 BOTTLE (68180-464-09)	2016-04-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SIMVASTATIN	St. Mary's Medical Park Pharmacy	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	5
SIMVASTATIN	Coupler LLC \| LUPIN LIMITED	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	1
SIMVASTATIN	Bryant Ranch Prepack	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	103
SIMVASTATIN	REMEDYREPACK INC.	2026-04-08	HUMAN PRESCRIPTION DRUG LABEL	10
SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	2026-02-26	HUMAN PRESCRIPTION DRUG LABEL	23
SIMVASTATIN	A-S Medication Solutions	2026-02-03	HUMAN PRESCRIPTION DRUG LABEL	12
SIMVASTATIN	A-S Medication Solutions	2026-02-03	HUMAN PRESCRIPTION DRUG LABEL	9
SIMVASTATIN	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	23
SIMVASTATIN	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Simvastatin	Legacy Pharmaceutical Packaging, LLC	2025-12-31	HUMAN PRESCRIPTION DRUG LABEL	12
SIMVASTATIN	QPharma, Inc. \| LUPIN LIMITED \| Northwind Health Company, LLC	2025-12-19	HUMAN PRESCRIPTION DRUG LABEL	4
Simvastatin	American Health Packaging	2025-05-20	HUMAN PRESCRIPTION DRUG LABEL	11
SIMVASTATIN	NuCare Pharmaceuticals,Inc.	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	2
Simvastatin	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	3
SIMVASTATIN	RPK Pharmaceuticals, Inc.	2023-09-11	HUMAN PRESCRIPTION DRUG LABEL	4
SIMVASTATIN	NuCare Pharmaceuticals,Inc.	2023-01-23	HUMAN PRESCRIPTION DRUG LABEL	1
SIMVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	2022-09-26	HUMAN PRESCRIPTION DRUG LABEL	7
SIMVASTATIN	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	4
SIMVASTATIN	NuCare Pharmaceuticals.Inc. \| NuCare Pharmaceuticals,Inc.	2020-08-28	HUMAN PRESCRIPTION DRUG LABEL	1