Lovastatin

Product NDC: 68084-559
11-digit product format: 680840559
Labeler code: 68084
Product ID: 68084-559_84eebf5e-442d-4530-e053-2a91aa0a18ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA075828
Marketing category: ANDA
Marketing start: 2012-01-06
Marketing end: 2020-08-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68084-559		D	Discontinued by firm		2026-07-31
excluded package	package	68084-559	68084-559-01	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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-559-01	EA - Each	68084-559	e99a78d2-8841-4845-a19b-8a1c3c248385	1	2012-07-24
68084-559-11	EA - Each	68084-559	e0ac5279-2187-4b80-991c-83fecf085623	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LOVASTATIN TABLETS, USP 8255901/1217 R x Only	American Health Packaging	2019-03-25	HUMAN PRESCRIPTION DRUG LABEL	10