Simvastatin

Product NDC: 70518-4102
Requested package NDC: 70518-4102-0
11-digit product format: 705184102
Labeler code: 70518
Product ID: 70518-4102_5a093198-2ce2-c1d1-e063-6294a90aad8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078034
Marketing category: ANDA
Marketing start: 2024-06-14
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
A078034-001	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20
A078034-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20
A078034-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20
A078034-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20
A078034-005	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
A078034-001	AB
A078034-002	AB
A078034-003	AB
A078034-004	AB
A078034-005	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	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-005	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	A078034-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078034-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078034-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078034-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078034-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078034-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078034-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078034-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-005	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
593f0007-9690-4de5-b1e9-59299e587643	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	Strength	SPL version
70518-4102-0	Simvastatin	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		3
70518-4102-1	Simvastatin	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4102	SIMVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.]	2	Current NDC, 2 package rows	20240716_593f0007-9690-4de5-b1e9-59299e587643.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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simvastatin	SIMVASTATIN	REMEDYREPACK INC.	593f0007-9690-4de5-b1e9-59299e587643	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034 ndc (package): 70518-4102-0 ndc (product): 70518-4102 ndc11 (package): 70518410200
Simvastatin	SIMVASTATIN	REMEDYREPACK INC.	d053fee4-b797-4a82-8865-0b4d08b14990	2026-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	58cd6c9a-3429-24eb-e063-6394a90a6984	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	55f92c72-e690-85dd-e063-6394a90adb39	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	522d0f7f-f20b-bc17-e063-6294a90a3648	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	REMEDYREPACK INC.	807e5be4-6f87-48b4-8a3b-e4ad1061e706	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Golden State Medical Supply, Inc.	4cc35f5f-2d3e-dedd-e063-6294a90a5cbe	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f68e9cf8-a63f-1d64-e053-2a95a90a4923	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f2f5ee7a-4f4e-12e9-e053-2a95a90a7eae	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	4277e75a-7f3b-4f35-ae56-0bbe095586a5	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	440dff4b-c377-48f3-bf24-07fd986b6fee	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	14bd8444-1556-4636-9e56-28da21a852fc	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Biocon Pharma Inc,	7b325108-6940-50a7-96b4-822a5206e568	2023-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	A-S Medication Solutions	34c8c080-97b5-4580-b8fb-3fd557cdb40a	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	c0a303c5-6277-47ce-bb8a-bd5400fd8261	2023-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	a753846e-4cd5-4ddc-a4f2-c45da571c883	2021-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	37860f3f-984e-419a-a262-3bacc766953e	2021-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034

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	593f0007-9690-4de5-b1e9-59299e587643	3
312962	simvastatin 5 MG Oral Tablet	SCD	593f0007-9690-4de5-b1e9-59299e587643	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4102-0	70518410200	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4102-0)	2024-06-14	No	No	Current