Lovastatin

Product NDC: 63739-281
11-digit product format: 637390281
Labeler code: 63739
Product ID: 63739-281_0a323fce-51c3-4ce0-9324-a4fdaf66c626
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: McKesson Corporation
Application: ANDA075828
Marketing category: ANDA
Marketing start: 2001-12-17
Marketing end: 0000-00-00
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: 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.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63739-281		D	Discontinued by firm		2026-07-31
excluded package	package	63739-281	63739-281-10	D	Discontinued by firm		2026-07-31

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63739-281-10	2021-07-16	C162847	48780-1	9d75b9d0-11c2-f424-e053-dadaa90a57ce	LOVASTATIN TABLETS, USP 40-8843 Revised – January 2008 Rx Only
63739-281-10	2020-01-31	C162847	48780-1	9d75b9d0-11c2-f424-e053-dadaa90a57ce	LOVASTATIN TABLETS, USP 40-8843 Revised – January 2008 Rx Only

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-281-10	EA - Each	63739-281	ceb0cb46-13c7-452e-a734-729b08385dc8	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lovastatin	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
lovastatin	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LOVASTATIN TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOVASTATIN TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	1

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 40-8843 Revised – January 2008 Rx Only	McKesson Corporation	2018-03-06	HUMAN PRESCRIPTION DRUG LABEL	4