Simvastatin

Product NDC: 50090-3922
Requested package NDC: 50090-3922-1
11-digit product format: 500903922
Labeler code: 50090
Product ID: 50090-3922_db5961ba-dcf6-4d53-b1da-330a9a588b6a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA200895
Marketing category: ANDA
Marketing start: 2014-12-09
Marketing end: 0000-00-00
Substance: SIMVASTATIN
Active strength: 80 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-3922	50090-3922-1	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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	Approval date
A200895-001	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25
A200895-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25
A200895-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25
A200895-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25
A200895-005	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200895-001	AB
A200895-002	AB
A200895-003	AB
A200895-004	AB
A200895-005	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`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	A200895-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200895-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-005	AB	1	`5bbf6a4d5a75…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3922-0	2023-01-30	C162847	48780-1	f386c64a-24ab-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
50090-3922-1	2023-01-30	C162847	48780-1	f386c64a-24ab-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3922-0	Simvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30		3
50090-3922-1	Simvastatin	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3922	SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 2 package rows	20190501_7a8d554b-5f4c-4e4d-a417-9502f114475b.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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simvastatin	SIMVASTATIN	XLCare Pharmaceuticals Inc.	433f8a86-5ad3-43db-8e62-c0812dd3d723	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200895 application number: ANDA200895
Simvastatin	SIMVASTATIN	Quallent Pharmaceuticals Health LLC	2b4255a7-f9f5-4235-8dbb-b0f03acbd624	2024-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200895 application number: ANDA200895
Simvastatin	SIMVASTATIN	Camber Pharmaceuticals, Inc.	751b79c6-bba8-4d29-b69c-a2ac6453fec8	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200895 application number: ANDA200895

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
200345	simvastatin 80 MG Oral Tablet	PSN	7a8d554b-5f4c-4e4d-a417-9502f114475b	3
200345	simvastatin 80 MG Oral Tablet	SCD	7a8d554b-5f4c-4e4d-a417-9502f114475b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3922-1	50090392201	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3922-1)	2014-12-09	0000-00-00	No	No	Current