Lovastatin

Product NDC: 51655-013
11-digit product format: 516550013
Labeler code: 51655
Product ID: 51655-013_eb5d4ec9-b37e-4bf8-906d-381d3f09cb7f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Pharmaceuticals, LLC
Application: ANDA075828
Marketing category: ANDA
Marketing start: 2014-11-04
Marketing end: 0000-00-00
Substance: LOVASTATIN
Active strength: 10 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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 product	product	51655-013		D	Discontinued by firm		2026-07-31
excluded package	package	51655-013	51655-013-26	D	Discontinued by firm		2026-07-31

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075828-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A075828-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075828-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075828-003	AB	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-013-26	2023-12-26	C162847	48780-1	9d75b9d0-39b2-f424-e053-dadaa90a57ce	Lovastatin
51655-013-26	2020-01-31	C162847	48780-1	9d75b9d0-39b2-f424-e053-dadaa90a57ce	Lovastatin

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1