Lovastatin

Product NDC: 68001-224
11-digit product format: 680010224
Labeler code: 68001
Product ID: 68001-224_096d8092-9961-4cf7-b3c8-8b94ee8a31f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA075636
Marketing category: ANDA
Marketing start: 2014-02-10
Marketing end: 2019-10-31
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: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68001-224		D	Discontinued by firm	2026-07-31
excluded package	package	68001-224	68001-224-00	D	Discontinued by firm	2026-07-31
excluded package	package	68001-224	68001-224-06	D	Discontinued by firm	2026-07-31
excluded package	package	68001-224	68001-224-08	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
A075636-001	LOVASTATIN	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17
A075636-002	LOVASTATIN	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17
A075636-003	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
A075636-001	AB
A075636-002	AB
A075636-003	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	A075636-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075636-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075636-003	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	A075636-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075636-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075636-003	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-224-00	EA - Each	68001-224	e7821bff-7fed-47ae-8741-a2e0cebaf70e	1	2014-04-03
68001-224-06	EA - Each	68001-224	c136cd83-256b-446a-8910-2d2e68da33fd	1	2014-04-03
68001-224-08	EA - Each	68001-224	675da151-71a5-4628-9d2e-c36619a4604e	1	2014-04-03