Simvastatin

Product NDC: 71335-2262
Requested package NDC: 71335-2262-1
11-digit product format: 713352262
Labeler code: 71335
Product ID: 71335-2262_7ca50ad7-4632-467d-b4c9-4e1850893eb0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077691
Marketing category: ANDA
Marketing start: 2006-12-20
Substance: SIMVASTATIN
Active strength: 5 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 43.

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 · 215 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
2026-09-14 22:38:34	2026-08	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077691-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077691-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077691-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077691-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077691-005	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SIMVASTATIN	5 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
312962	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
a3bfe314-1fe4-4d2a-aecb-4194f3bd8f22	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
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
71335-2262-1	Simvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30	101
71335-2262-2	Simvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90	101
71335-2262-3	Simvastatin	60 in 1 BOTTLE	TABLET, FILM COATED	60	101
71335-2262-4	Simvastatin	10 in 1 BOTTLE	TABLET, FILM COATED	10	101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2262	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	101	Current NDC, 4 package rows	20240420_a3bfe314-1fe4-4d2a-aecb-4194f3bd8f22.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 · 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 ndc (package): 71335-2262-1 ndc (product): 71335-2262 ndc11 (package): 71335226201
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
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
312962	simvastatin 5 MG Oral Tablet	PSN	a3bfe314-1fe4-4d2a-aecb-4194f3bd8f22	101
312962	simvastatin 5 MG Oral Tablet	SCD	a3bfe314-1fe4-4d2a-aecb-4194f3bd8f22	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2262-1	71335226201	30 TABLET, FILM COATED in 1 BOTTLE (71335-2262-1)	2024-04-03	No	No	Current