Lovastatin

Product NDC: 70934-658
11-digit product format: 709340658
Labeler code: 70934
Product ID: 70934-658_aa6c8a42-c62a-b871-e053-2a95a90a5c5f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application: ANDA075991
Marketing category: ANDA
Marketing start: 2020-04-07
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70934-658		D	Discontinued by firm	2026-08-03
excluded package	package	70934-658	70934-658-30	D	Discontinued by firm	2026-08-03
excluded package	package	70934-658	70934-658-90	D	Discontinued by firm	2026-08-03

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-658-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-658-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-658-90	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-658-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-658-90	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-658-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-658-90	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-658-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-658-90	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-658-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-658-90	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-658-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-658-90	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-658-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70934-658-90	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70934-658-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70934-658-90	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70934-658-30	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70934-658-90	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70934-658-30	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70934-658-90	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70934-658-30	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70934-658-90	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70934-658-30	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70934-658-90	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70934-658-30	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70934-658-90	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70934-658-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70934-658-90	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70934-658-30	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
A075991-001	LOVASTATIN	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05
A075991-002	LOVASTATIN	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05
A075991-003	LOVASTATIN	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075991-001	AB
A075991-002	AB
A075991-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075991-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075991-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075991-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075991-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075991-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075991-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075991-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075991-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075991-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075991-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075991-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075991-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075991-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075991-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075991-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075991-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075991-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075991-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075991-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075991-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075991-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075991-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075991-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075991-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075991-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075991-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075991-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075991-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075991-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075991-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075991-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075991-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075991-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075991-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075991-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075991-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075991-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075991-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075991-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075991-001	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70934-658-30	2023-01-30	Lovastatin Tablet USP Revision M
70934-658-90	2023-01-30	Lovastatin Tablet USP Revision M
70934-658-30	2022-01-28	Lovastatin Tablet USP Revision M
70934-658-90	2022-01-28	Lovastatin Tablet USP Revision M

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70934-658-30	EA - Each	70934-658	3c6790c5-db56-48fa-8e5f-422ded13285d	1	2022-12-07
70934-658-90	EA - Each	70934-658	fd5b0e45-fbf6-4680-86cc-0303b8f4dc29	1	2022-12-07

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	REMEDYREPACK INC.	9438d8a0-ca5b-4676-aab9-d0241ccff6c9	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals Inc.	56680dfa-abe6-4587-b222-364315fd78f4	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals, Inc.	ea4df37b-21e9-4dc3-83af-1be1b50bfdc9	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	7fd9d5c7-8025-4049-8b5b-ae3d22db507f	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Northwind Health Company, LLC	db47ddae-c574-427f-e053-2a95a90aae48	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	A-S Medication Solutions	dd7a223e-7fc5-4eb0-9bd7-2f9a2d6b4173	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	A-S Medication Solutions	bfb889a4-5751-4706-9fa7-f48672c1bc08	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	220a9b3c-c583-49e3-8bf0-d0c97dc9b829	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	c37206ae-52f1-4192-9ab9-3044247cf58d	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	ac86821f-d741-4ab1-bd03-ce8797dd4f34	2025-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	70e2bf86-4a78-4dfb-b6b1-8eb95f63684d	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	eea93a4b-f804-4b9c-aabf-e906f03c1e80	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	2eff3e5e-8746-048e-e063-6294a90a38c4	2025-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Carlsbad Technology, Inc.	0a680e13-0356-4e08-a7fe-78b96ba51b9d	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	c871a6a7-67a4-4ac1-b102-3f1604625c7d	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals, Inc.	415c2698-7787-49f8-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals, Inc.	4444573e-9df1-01e6-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	8d8199ca-df39-4eb8-a905-dee3ab7e2973	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	5684ceb8-a5b2-4fb4-92be-14aabcea3871	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	ad905651-6e3a-4140-aa37-d91e5f37c0f0	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991

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
70934-658-30	70934065830	30 TABLET in 1 BOTTLE, PLASTIC (70934-658-30)	30 tablet	2020-05-01	0000-00-00	No	No	Current
70934-658-90	70934065890	90 TABLET in 1 BOTTLE, PLASTIC (70934-658-90)	90 tablet	2020-04-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lovastatin Tablet USP Revision M	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-24	HUMAN PRESCRIPTION DRUG LABEL	2