Simvastatin

Product NDC: 43353-858
Requested package NDC: 43353-858-98
11-digit product format: 433530858
Labeler code: 43353
Product ID: 43353-858_f9ed59e7-0b07-4129-afb9-e7e546575a0b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA077691
Marketing category: ANDA
Marketing start: 2006-12-20
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	43353-858	43353-858-98	I	Inactivated by FDA		2026-08-07

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
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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43353-858-15	These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin Tablets, USP Initial U.S. Approval: 1991
43353-858-19	These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin Tablets, USP Initial U.S. Approval: 1991
43353-858-30	These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin Tablets, USP Initial U.S. Approval: 1991
43353-858-45	These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin Tablets, USP Initial U.S. Approval: 1991
43353-858-60	These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin Tablets, USP Initial U.S. Approval: 1991
43353-858-98	These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin Tablets, USP Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-858-15	Simvastatin	15 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	15	2
43353-858-19	Simvastatin	3060 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	3060	2
43353-858-30	Simvastatin	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	2
43353-858-45	Simvastatin	45 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	45	2
43353-858-60	Simvastatin	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	2
43353-858-98	Simvastatin	540 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	540	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-858-15	EA - Each	43353-858	f73f95dd-763a-423d-84e2-5f67f998a0b9	1	2014-07-02
43353-858-19	EA - Each	43353-858	b407a6b0-1873-4841-82d5-d64a88dfb1a1	1	2014-07-02
43353-858-30	EA - Each	43353-858	8859db48-c1a2-4d42-b045-be8941b9ef5b	1	2014-07-02
43353-858-45	EA - Each	43353-858	9ecc8952-31ef-4f32-bb4b-aa9676f4ba3c	1	2014-07-02
43353-858-60	EA - Each	43353-858	e202281d-f866-4aa4-8699-afabb0e2a972	1	2014-07-02
43353-858-98	EA - Each	43353-858	789ea0f7-11c5-4fd9-91dd-4b9d23ac4da8	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-858	SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 6 package rows	20191224_1d7c107b-64f3-41b0-88c5-4f38dc58ceaf.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
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
314231	simvastatin 10 MG Oral Tablet	PSN	1d7c107b-64f3-41b0-88c5-4f38dc58ceaf	2
312961	simvastatin 20 MG Oral Tablet	PSN	1d7c107b-64f3-41b0-88c5-4f38dc58ceaf	2
198211	simvastatin 40 MG Oral Tablet	PSN	1d7c107b-64f3-41b0-88c5-4f38dc58ceaf	2
312962	simvastatin 5 MG Oral Tablet	PSN	1d7c107b-64f3-41b0-88c5-4f38dc58ceaf	2
200345	simvastatin 80 MG Oral Tablet	PSN	1d7c107b-64f3-41b0-88c5-4f38dc58ceaf	2
314231	simvastatin 10 MG Oral Tablet	SCD	1d7c107b-64f3-41b0-88c5-4f38dc58ceaf	2
312961	simvastatin 20 MG Oral Tablet	SCD	1d7c107b-64f3-41b0-88c5-4f38dc58ceaf	2
198211	simvastatin 40 MG Oral Tablet	SCD	1d7c107b-64f3-41b0-88c5-4f38dc58ceaf	2
312962	simvastatin 5 MG Oral Tablet	SCD	1d7c107b-64f3-41b0-88c5-4f38dc58ceaf	2
200345	simvastatin 80 MG Oral Tablet	SCD	1d7c107b-64f3-41b0-88c5-4f38dc58ceaf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-858-98	43353085898	540 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-858-98)	2013-12-05	0000-00-00	No	No	Current