Simvastatin

Product NDC: 65841-067
11-digit product format: 658410067
Labeler code: 65841
Product ID: 65841-067_f6a1f948-fffb-40ff-a5fc-e6767c93957d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA077837
Marketing category: ANDA
Marketing start: 2006-12-20
Marketing end: 0000-00-00
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: 2023-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65841-067		D	Discontinued by firm	2026-10-15
excluded package	package	65841-067	65841-067-05	D	Discontinued by firm	2026-10-15
excluded package	package	65841-067	65841-067-06	D	Discontinued by firm	2026-10-15
excluded package	package	65841-067	65841-067-10	D	Discontinued by firm	2026-10-15
excluded package	package	65841-067	65841-067-14	D	Discontinued by firm	2026-10-15
excluded package	package	65841-067	65841-067-16	D	Discontinued by firm	2026-10-15
excluded package	package	65841-067	65841-067-24	D	Discontinued by firm	2026-10-15

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-067-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-067-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-067-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-067-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-067-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-067-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-067-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-067-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-067-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-067-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-067-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-067-16	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077837-001	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20
A077837-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20
A077837-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20
A077837-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20
A077837-005	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
A077837-001	AB
A077837-002	AB
A077837-003	AB
A077837-004	AB
A077837-005	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 · 220 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
2026-10-15 13:18:30	2026-09	A077837-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077837-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077837-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077837-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077837-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077837-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077837-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077837-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077837-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077837-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077837-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077837-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077837-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077837-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077837-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077837-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077837-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077837-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077837-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077837-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077837-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077837-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077837-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077837-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077837-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077837-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077837-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077837-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077837-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077837-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077837-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077837-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077837-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077837-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077837-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077837-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077837-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077837-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077837-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077837-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A077837-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077837-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077837-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077837-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077837-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077837-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077837-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077837-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077837-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077837-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077837-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077837-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077837-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077837-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077837-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077837-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077837-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077837-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077837-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077837-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077837-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077837-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077837-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077837-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077837-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077837-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077837-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077837-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077837-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077837-005	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077837-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077837-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077837-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077837-004	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077837-005	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077837-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077837-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077837-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077837-004	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077837-005	AB	1	`1c564ffb4f44…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	4

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AGG2FN16EV	SIMVASTATIN	79902-63-9	SIMVASTATIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-067-05	65841006705	500 TABLET, FILM COATED in 1 BOTTLE (65841-067-05)	2006-12-20	0000-00-00	No	No	Current
65841-067-06	65841006706	30 TABLET, FILM COATED in 1 BOTTLE (65841-067-06)	2006-12-20	0000-00-00	No	No	Current
65841-067-10	65841006710	1000 TABLET, FILM COATED in 1 BOTTLE (65841-067-10)	2006-12-20	0000-00-00	No	No	Current
65841-067-14	65841006714	60 TABLET, FILM COATED in 1 BOTTLE (65841-067-14)	2006-12-20	0000-00-00	No	No	Current
65841-067-16	65841006716	90 TABLET, FILM COATED in 1 BOTTLE (65841-067-16)	2006-12-20	0000-00-00	No	No	Current
65841-067-24	65841006724	10000 TABLET, FILM COATED in 1 BOTTLE (65841-067-24)	2006-12-20	0000-00-00	No	No	Current