Lovastatin

Product NDC: 71610-396
Requested package NDC: 71610-396-45
11-digit product format: 716100396
Labeler code: 71610
Product ID: 71610-396_1d0478b8-c84a-425f-b686-56daf6eb1270
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA075551
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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71610-396	71610-396-45	I	Inactivated by FDA		2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075551-001	LOVASTATIN	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17
A075551-002	LOVASTATIN	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17
A075551-003	LOVASTATIN	LOVASTATIN	10MG	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
A075551-001	AB
A075551-002	AB
A075551-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075551-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075551-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075551-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075551-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075551-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075551-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075551-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075551-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075551-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075551-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075551-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075551-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075551-001	AB	1	`1e350fbaab3a…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71610-396-45	2023-01-30	C162847	48780-1	f386c64a-365f-0266-e053-dadaa90a7c1a	LOVASTATIN TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-396-45	Lovastatin	45 in 1 BOTTLE	TABLET	45		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-396-45	EA - Each	71610-396	fe127964-6b1d-4bf0-8ad1-83ca82f487cb	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-396	LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 1 package rows	20200319_65e0bfa6-fd11-4fda-bec5-359201da60a0.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	REMEDYREPACK INC.	a902a95f-072a-4487-99a9-109a93f8b23c	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551
Lovastatin	LOVASTATIN	Golden State Medical Supply, Inc.	91332c54-1a27-4e6b-e053-2a95a90a42cd	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551
Lovastatin	LOVASTATIN	A-S Medication Solutions	4ff981e8-5c86-4b86-baa1-825551905ed8	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551
Lovastatin	LOVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	7e96b174-3887-4908-9b9f-5ef93540f96a	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551
Lovastatin	LOVASTATIN	Teva Pharmaceuticals USA, Inc.	0e15feec-d27e-4861-8152-c5a8b8ccacd4	2020-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551
Lovastatin	LOVASTATIN	Proficient Rx LP	027bd594-6a0a-4e6d-bd3c-4f33fdb4166a	2020-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551

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
197905	lovastatin 40 MG Oral Tablet	PSN	65e0bfa6-fd11-4fda-bec5-359201da60a0	1
197905	lovastatin 40 MG Oral Tablet	SCD	65e0bfa6-fd11-4fda-bec5-359201da60a0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-396-45	71610039645	45 TABLET in 1 BOTTLE (71610-396-45)	45 tablet	2020-02-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LOVASTATIN TABLETS USP Rx only	Aphena Pharma Solutions - Tennessee, LLC	2020-03-06	HUMAN PRESCRIPTION DRUG LABEL	1