Simvastatin

Product NDC: 42571-020
11-digit product format: 425710020
Labeler code: 42571
Product ID: 42571-020_0369d423-9ef2-0191-e063-6294a90a55e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA090383
Marketing category: ANDA
Marketing start: 2013-06-13
Substance: SIMVASTATIN
Active strength: 20 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42571-020		D	Discontinued by firm	2026-08-17
excluded package	package	42571-020	42571-020-05	D	Discontinued by firm	2026-08-17
excluded package	package	42571-020	42571-020-10	D	Discontinued by firm	2026-08-17
excluded package	package	42571-020	42571-020-30	D	Discontinued by firm	2026-08-17
excluded package	package	42571-020	42571-020-60	D	Discontinued by firm	2026-08-17
excluded package	package	42571-020	42571-020-90	D	Discontinued by firm	2026-08-17

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
A090383-001	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16
A090383-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16
A090383-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16
A090383-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16
A090383-005	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090383-001	AB
A090383-002	AB
A090383-003	AB
A090383-004	AB
A090383-005	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	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`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	A090383-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090383-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090383-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090383-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090383-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090383-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090383-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-005	AB	1	`2680178bc6a6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5347abc9-d72b-9efb-f582-cc87efafcf1b	Product name	4	20250729
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
42571-020-05	Simvastatin	500 in 1 BOTTLE	TABLET	500	90400
42571-020-10	Simvastatin	1000 in 1 BOTTLE	TABLET	1000	90400
42571-020-30	Simvastatin	30 in 1 BOTTLE	TABLET	30	90400
42571-020-60	Simvastatin	60 in 1 BOTTLE	TABLET	60	90400
42571-020-90	Simvastatin	90 in 1 BOTTLE	TABLET	90	90400

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-020-10	EA - Each	42571-020	e1b59430-0a2e-4c2a-b0f7-410bf88635c1	1	2013-04-01
42571-020-90	EA - Each	42571-020	e90920a8-3371-4d96-8c8d-4d3f91ad1f7b	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET [MICRO LABS LIMITED]	90388

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-020	SIMVASTATIN (SIMVASTATIN) TABLET [MICRO LABS LIMITED]	90400	Current NDC, Legacy NDC, 5 package rows	20230822_5c1c694c-4b08-469e-b538-08e69df06146.zip

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
314231	simvastatin 10 MG Oral Tablet	PSN	5c1c694c-4b08-469e-b538-08e69df06146	90400
312961	simvastatin 20 MG Oral Tablet	PSN	5c1c694c-4b08-469e-b538-08e69df06146	90400
198211	simvastatin 40 MG Oral Tablet	PSN	5c1c694c-4b08-469e-b538-08e69df06146	90400
312962	simvastatin 5 MG Oral Tablet	PSN	5c1c694c-4b08-469e-b538-08e69df06146	90400
200345	simvastatin 80 MG Oral Tablet	PSN	5c1c694c-4b08-469e-b538-08e69df06146	90400
314231	simvastatin 10 MG Oral Tablet	SCD	5c1c694c-4b08-469e-b538-08e69df06146	90400
312961	simvastatin 20 MG Oral Tablet	SCD	5c1c694c-4b08-469e-b538-08e69df06146	90400
198211	simvastatin 40 MG Oral Tablet	SCD	5c1c694c-4b08-469e-b538-08e69df06146	90400
312962	simvastatin 5 MG Oral Tablet	SCD	5c1c694c-4b08-469e-b538-08e69df06146	90400
200345	simvastatin 80 MG Oral Tablet	SCD	5c1c694c-4b08-469e-b538-08e69df06146	90400

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-020-05	42571002005	500 TABLET in 1 BOTTLE (42571-020-05)	500 tablet	2013-06-13	0000-00-00	No	No	Current
42571-020-10	42571002010	1000 TABLET in 1 BOTTLE (42571-020-10)	1000 tablet	2013-06-13	0000-00-00	No	No	Current
42571-020-30	42571002030	30 TABLET in 1 BOTTLE (42571-020-30)	30 tablet	2013-06-13	0000-00-00	No	No	Current
42571-020-60	42571002060	60 TABLET in 1 BOTTLE (42571-020-60)	60 tablet	2013-06-13	0000-00-00	No	No	Current
42571-020-90	42571002090	90 TABLET in 1 BOTTLE (42571-020-90)	90 tablet	2013-06-13	0000-00-00	No	No	Current