Lovastatin

Product NDC: 60429-402
11-digit product format: 604290402
Labeler code: 60429
Product ID: 60429-402_c9eebb1d-94dd-dd54-e053-2a95a90a9a0c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA075828
Marketing category: ANDA
Marketing start: 2001-12-17
Marketing end: 0000-00-00
Substance: LOVASTATIN
Active strength: 40 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60429-402		D	Discontinued by firm	2026-10-15
excluded package	package	60429-402	60429-402-10	D	Discontinued by firm	2026-10-15
excluded package	package	60429-402	60429-402-60	D	Discontinued by firm	2026-10-15
excluded package	package	60429-402	60429-402-90	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 · 48 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	60429-402-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60429-402-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60429-402-10	`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	60429-402-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60429-402-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60429-402-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60429-402-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60429-402-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60429-402-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60429-402-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60429-402-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60429-402-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60429-402-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60429-402-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60429-402-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60429-402-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60429-402-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60429-402-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60429-402-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60429-402-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60429-402-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60429-402-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60429-402-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60429-402-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60429-402-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60429-402-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60429-402-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60429-402-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60429-402-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60429-402-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60429-402-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60429-402-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60429-402-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60429-402-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60429-402-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60429-402-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075828-001	LOVASTATIN	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17
A075828-002	LOVASTATIN	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17
A075828-003	LOVASTATIN	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075828-001	AB
A075828-002	AB
A075828-003	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 4 · 132 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	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A075828-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075828-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075828-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075828-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075828-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075828-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075828-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075828-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075828-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075828-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075828-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075828-003	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60429-402-10	EA - Each	60429-402	3b06e110-fc2d-4c3f-9870-64f246dc72b4	1	2015-01-05
60429-402-60	EA - Each	60429-402	1e07c1d2-f8c3-4510-90e3-19a9a6e870dd	1	2015-01-05
60429-402-90	EA - Each	60429-402	42313b20-3cfa-4022-90c7-bdc8d833ec48	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9LHU78OQFD	LOVASTATIN	75330-75-5	LOVASTATIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60429-402-10	60429040210	1000 TABLET in 1 BOTTLE (60429-402-10)	1000 tablet	2014-06-24	2021-03-31	No	No	Current
60429-402-60	60429040260	60 TABLET in 1 BOTTLE (60429-402-60)	60 tablet	2014-06-24	2021-03-31	No	No	Current
60429-402-90	60429040290	90 TABLET in 1 BOTTLE (60429-402-90)	90 tablet	2014-06-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LOVASTATIN TABLETS, USP	Golden State Medical Supply, Inc.	2021-11-29	HUMAN PRESCRIPTION DRUG LABEL	9
LOVASTATIN TABLETS, USP	Aphena Pharma Solutions - Tennessee, LLC	2016-06-14	HUMAN PRESCRIPTION DRUG LABEL	1