Lovastatin

Product NDC: 68071-3261
11-digit product format: 680713261
Labeler code: 68071
Product ID: 68071-3261_2d540607-1803-4063-e063-6294a90a7159
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA078296
Marketing category: ANDA
Marketing start: 2007-11-01
Substance: LOVASTATIN
Active strength: 20 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 12 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
2025-02-02 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	68071-3261-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3261-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3261-9	`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	68071-3261-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3261-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3261-9	`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	68071-3261-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3261-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3261-9	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078296-001	LOVASTATIN	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14
A078296-002	LOVASTATIN	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01
A078296-003	LOVASTATIN	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078296-001	AB
A078296-002	AB
A078296-003	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 · 129 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	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A078296-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078296-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078296-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078296-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078296-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078296-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078296-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078296-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078296-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078296-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078296-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078296-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078296-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078296-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078296-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078296-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078296-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078296-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078296-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078296-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078296-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078296-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078296-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078296-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078296-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078296-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078296-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078296-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078296-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078296-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078296-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078296-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078296-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078296-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078296-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078296-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078296-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078296-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078296-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078296-001	AB	1	`301d65b070ca…`

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: Lovastatin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOVASTATIN	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9LHU78OQFD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197904	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
50217921-97a7-6ff2-e054-00144ff88e88	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212	Product name	1	20140508
f1ae760e-e8ec-b0b4-fb1b-2db7c49fcec5	Product name	1	20140508
fecc3d5d-ff9a-60ad-1a3a-6cb9b21df758	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-3261-3	2025-02-04	LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
68071-3261-6	2025-02-04	LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
68071-3261-9	2025-02-04	LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
68071-3261-3	2025-01-30	LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
68071-3261-6	2025-01-30	LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
68071-3261-9	2025-01-30	LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-3261-3	Lovastatin	30 in 1 BOTTLE	TABLET	30	6
68071-3261-6	Lovastatin	60 in 1 BOTTLE	TABLET	60	6
68071-3261-9	Lovastatin	90 in 1 BOTTLE	TABLET	90	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3261	LOVASTATIN TABLET [NUCARE PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 3 package rows	20250206_50217921-97a7-6ff2-e054-00144ff88e88.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	Proficient Rx LP	f9e27117-db98-48bc-b7bc-fc98c9b719cf	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197904	lovastatin 20 MG Oral Tablet	PSN	50217921-97a7-6ff2-e054-00144ff88e88	6
197904	lovastatin 20 MG Oral Tablet	SCD	50217921-97a7-6ff2-e054-00144ff88e88	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-3261-3	68071326103	30 TABLET in 1 BOTTLE (68071-3261-3)	30 tablet	2017-05-22	0000-00-00	No	No	Current
68071-3261-6	68071326106	60 TABLET in 1 BOTTLE (68071-3261-6)	60 tablet	2017-05-22	0000-00-00	No	No	Current
68071-3261-9	68071326109	90 TABLET in 1 BOTTLE (68071-3261-9)	90 tablet	2017-05-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	NuCare Pharmaceuticals, Inc.	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	6