SIMVASTATIN

Product NDC: 68180-482
11-digit product format: 681800482
Labeler code: 68180
Product ID: 68180-482_b78d4e8a-2261-43c6-9321-ac2539bdfd2f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SIMVASTATIN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA078103
Marketing category: ANDA
Marketing start: 2009-07-14
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68180-482	68180-482-06	D	Discontinued by firm		2026-10-05
excluded package	package	68180-482	68180-482-09	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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	68180-482-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	68180-482-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	68180-482-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	68180-482-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	68180-482-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	68180-482-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	68180-482-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	68180-482-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	68180-482-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	68180-482-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	68180-482-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	68180-482-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	68180-482-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	68180-482-06	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	68180-482-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	68180-482-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	68180-482-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	68180-482-06	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	68180-482-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	68180-482-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	68180-482-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	68180-482-06	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	68180-482-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	68180-482-06	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	RLD / RS	Approval date
A078103-001	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11
A078103-002	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11
A078103-003	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11
A078103-004	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11
A078103-005	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078103-001	AB
A078103-002	AB
A078103-003	AB
A078103-004	AB
A078103-005	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`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	A078103-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078103-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078103-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078103-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-005	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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198211	Internal RxNorm lookup
200345	Internal RxNorm lookup
312961	Internal RxNorm lookup
312962	Internal RxNorm lookup
314231	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
3e48217f-8175-4e9b-9fd0-909be4bbba95	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
68180-482-03	SIMVASTATIN	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	23
68180-482-06	SIMVASTATIN	30 in 1 BOTTLE	TABLET, FILM COATED	30	23
68180-482-09	SIMVASTATIN	90 in 1 BOTTLE	TABLET, FILM COATED	90	23
68180-482-11	SIMVASTATIN	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-482-06	EA - Each	68180-482	c533bd1d-a39e-497c-a163-7660c9a1822a	1	2012-07-24
68180-482-09	EA - Each	68180-482	48f67417-c02b-4677-8f20-92e161739b13	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-482	SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	21	Current NDC, Legacy NDC, 4 package rows	20250515_3e48217f-8175-4e9b-9fd0-909be4bbba95.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 2 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIMVASTATIN	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	25d9f841-31d8-4514-ac73-ffe138ff69c7	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	aaca7284-d2d8-42e3-b153-ddc3d2ce907c	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	76ea62f3-4efb-4649-829d-3f0c28d5dae7	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	d099d003-4c7c-4e35-ad6e-94ddf20035b7	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	3b0720d2-b240-48e4-af77-9ccda509fae7	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	30fe2447-4dd3-43e6-bac5-0f754ab77c3a	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	3e48217f-8175-4e9b-9fd0-909be4bbba95	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103 ndc (product): 68180-482
SIMVASTATIN	SIMVASTATIN	Northwind Health Company, LLC	f835af8f-7d84-1978-e053-6294a90a22ae	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Northwind Health Company, LLC	f86de805-e4ec-4bca-e053-6294a90a1fc3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	8e686832-1caf-425c-9ca6-7eaade43b6fe	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	QPharma, Inc.	f71f71db-e0dd-6609-e053-6294a90a4450	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	09fa512b-f6c1-437d-be46-a8ddd36743b4	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	a53cfdd8-ca99-47a9-827d-1b06a0329878	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	450e722c-d55d-3e6d-e063-6394a90a5231	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
Simvastatin	SIMVASTATIN	American Health Packaging	4bec3923-6221-4b8b-9a72-872a63680de1	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
Simvastatin	SIMVASTATIN	American Health Packaging	51dd8d34-e660-49dc-a86e-07d031a18465	2025-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	06703194-b41a-2bbe-e063-6394a90ac41f	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	673dfc44-d407-f9ac-e053-2a91aa0a4702	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
Simvastatin	SIMVASTATIN	Direct_Rx	f42246de-62d2-212f-e053-2a95a90ac88a	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
Simvastatin	SIMVASTATIN	Direct_Rx	f5dd1835-6d40-40da-e053-2a95a90ad121	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103

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	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
312961	simvastatin 20 MG Oral Tablet	PSN	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
198211	simvastatin 40 MG Oral Tablet	PSN	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
312962	simvastatin 5 MG Oral Tablet	PSN	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
200345	simvastatin 80 MG Oral Tablet	PSN	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
314231	simvastatin 10 MG Oral Tablet	SCD	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
312961	simvastatin 20 MG Oral Tablet	SCD	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
198211	simvastatin 40 MG Oral Tablet	SCD	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
312962	simvastatin 5 MG Oral Tablet	SCD	3e48217f-8175-4e9b-9fd0-909be4bbba95	23
200345	simvastatin 80 MG Oral Tablet	SCD	3e48217f-8175-4e9b-9fd0-909be4bbba95	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-482-03	68180048203	1000 TABLET, FILM COATED in 1 BOTTLE (68180-482-03)	2009-07-14	0000-00-00	No	No	Current
68180-482-06	68180048206	30 in 1 BOTTLE					Historical
68180-482-09	68180048209	90 in 1 BOTTLE					Historical
68180-482-11	68180048211	10 in 1 BLISTER PACK					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SIMVASTATIN	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	23