Simvastatin

Product NDC: 50090-7783
11-digit product format: 500907783
Labeler code: 50090
Product ID: 50090-7783_feeb1a34-4f38-4a9a-a620-6c3192d223b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077691
Marketing category: ANDA
Marketing start: 2006-12-20
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: 2026-12-31
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	Approval date
A077691-001	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20
A077691-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20
A077691-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20
A077691-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20
A077691-005	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077691-001	AB
A077691-002	AB
A077691-003	AB
A077691-004	AB
A077691-005	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	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`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	A077691-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077691-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077691-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077691-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077691-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077691-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077691-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077691-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077691-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077691-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077691-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077691-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077691-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077691-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077691-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077691-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077691-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077691-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SIMVASTATIN	80 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200345	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
02245025-218d-4297-aeb6-91fefa178291	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
50090-7783-0	Simvastatin	45 in 1 BOTTLE	TABLET, FILM COATED	45	1
50090-7783-1	Simvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90	1
50090-7783-2	Simvastatin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	1

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 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	a3bfe314-1fe4-4d2a-aecb-4194f3bd8f22	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	Aurobindo Pharma Limited	4724dbb4-3613-4e6a-948f-a43d34f97f06	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f7567996-4e81-7c12-e053-6394a90aa087	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	468f87c8-75e3-444a-baeb-2d0f629802db	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	02245025-218d-4297-aeb6-91fefa178291	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691 ndc (product): 50090-7783
Simvastatin	SIMVASTATIN	A-S Medication Solutions	20fa794a-c30a-485e-9e69-3818ba085a0d	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	9986b59c-aeff-4ccd-8db3-7f1c4e619420	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	7cbf645d-b1d3-413d-a4c3-c1818ed6dfd1	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	4312637b-1d6a-4d26-a1e8-caffcd7192df	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	a2b879ae-eaf3-4a36-abd0-986add4a73ac	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	66777aaa-370a-4121-9246-c0866098f4a4	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	658cf877-f7cd-4ec8-84a3-08c27a06ccda	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	6de29f85-92e9-4a28-9bcc-6789f2f698de	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	9133520e-1ffd-4ef1-bced-6b0c9a579f39	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	492f6b4e-ca25-4f59-9f9d-3f465061b7b1	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	cf85b795-82fa-3389-e053-2995a90af2fd	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	cf859977-2d84-0fcb-e053-2a95a90a6269	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	0a1fe17b-75d4-d361-e063-6394a90ae188	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	NorthStar Rx LLC	0376351b-f1a0-43e5-a0b4-533072c49f39	2024-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691
Simvastatin	SIMVASTATIN	A-S Medication Solutions	2e579278-c105-4cda-92ca-a3496d846c82	2024-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077691 application number: ANDA077691

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	02245025-218d-4297-aeb6-91fefa178291	1
200345	simvastatin 80 MG Oral Tablet	SCD	02245025-218d-4297-aeb6-91fefa178291	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-7783-0	50090778300	45 TABLET, FILM COATED in 1 BOTTLE (50090-7783-0)	2025-11-20	No	No	Current
50090-7783-1	50090778301	90 TABLET, FILM COATED in 1 BOTTLE (50090-7783-1)	2025-11-20	No	No	Current
50090-7783-2	50090778302	1000 TABLET, FILM COATED in 1 BOTTLE (50090-7783-2)	2025-11-20	No	No	Current