simvastatin

Product NDC: 68788-9747
11-digit product format: 687889747
Labeler code: 68788
Product ID: 68788-9747_a6a377c0-6795-4d61-8c65-678cfdf04aaf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA078155
Marketing category: ANDA
Marketing start: 2012-02-28
Marketing end: 0000-00-00
Substance: SIMVASTATIN
Active strength: 10 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-9747		D	Discontinued by firm	2026-10-05
excluded package	package	68788-9747	68788-9747-1	D	Discontinued by firm	2026-10-05
excluded package	package	68788-9747	68788-9747-3	D	Discontinued by firm	2026-10-05
excluded package	package	68788-9747	68788-9747-6	D	Discontinued by firm	2026-10-05
excluded package	package	68788-9747	68788-9747-9	D	Discontinued by firm	2026-10-05

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 · 5 matching rows.

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

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	68788-9747-6
excluded package	package	68788-9747-3
excluded package	package	68788-9747-9
excluded package	package	68788-9747-1

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
A078155-001	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26
A078155-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26
A078155-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26
A078155-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26
A078155-005	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078155-001	AB
A078155-002	AB
A078155-003	AB
A078155-004	AB
A078155-005	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	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-001	SIMVASTATIN	80MG	TABLET / ORAL	AB	2008-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2008-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2008-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2008-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2013-04-05	`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	A078155-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078155-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078155-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078155-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078155-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078155-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078155-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078155-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078155-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078155-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078155-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078155-005	AB	1	`03ed91905a0d…`

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 [PREFERRED PHARMACEUTICALS, INC.]	4
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-9747	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	13	Legacy NDC	20240810_7442f35f-74e8-4c35-9666-190a3baad549.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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	aa8aed58-691b-472e-8e98-53d0d3f56686	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	7463b093-c2ee-49c3-a08a-e758de66422a	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	c6b610ab-7367-4e61-9b4a-7ebbd1cf3d36	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	c03ab80c-a3ae-4634-a76b-f53740db76f5	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Northwind Health Company, LLC	db0f4c5a-e8e4-3ab1-e053-2995a90a1f9a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f32d512f-86fa-b70f-e053-2a95a90afd01	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	QPharma, Inc.	c80b823c-b30f-0a9d-e053-2995a90a31e9	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Accord Healthcare, Inc.	871251c0-36a1-4a32-9eab-ff6c1e925ca9	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	56456210-2db5-4f0d-e054-00144ff8d46c	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	b6d5fb21-a1a8-53e5-80d9-dde0eede5ef5	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	356ed6a6-e467-4791-87ff-2ae7779fc1b0	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	ce3ac5e8-bdef-d195-e0a0-e1a982008efe	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	79ca09cd-2396-4e50-b159-1f9567115067	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	54c236ce-69c2-06ef-e054-00144ff88e88	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	54c28733-eb99-10f6-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	8ed46bb1-9f84-4418-e053-2a95a90abd4b	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	8e986df7-3020-6755-e053-2995a90aca37	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	A-S Medication Solutions	aaeebbc3-2608-41b5-8420-5a2a80316d39	2023-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Proficient Rx LP	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155
simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	b5bebcd0-84e6-410d-af96-63834d262bad	2021-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078155 application number: ANDA078155

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
68788-9747-1	68788974701	100 TABLET, FILM COATED in 1 BOTTLE (68788-9747-1)	2012-02-28	0000-00-00	No	No	Current
68788-9747-3	68788974703	30 TABLET, FILM COATED in 1 BOTTLE (68788-9747-3)	2012-02-28	0000-00-00	No	No	Current
68788-9747-6	68788974706	60 TABLET, FILM COATED in 1 BOTTLE (68788-9747-6)	2012-02-28	0000-00-00	No	No	Current
68788-9747-9	68788974709	90 TABLET, FILM COATED in 1 BOTTLE (68788-9747-9)	2012-02-28	0000-00-00	No	No	Current