Lovastatin

Product NDC
49999-293
11-digit product format
499990293
Labeler code
49999
Product ID
49999-293_4a056a61-f190-446a-8049-30d4ff0c6b2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA075828
Marketing category
ANDA
Marketing start
2001-12-17
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
2020-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49999-293DDiscontinued by firm2026-07-31
excluded packagepackage49999-29349999-293-30DDiscontinued by firm2026-07-31
excluded packagepackage49999-29349999-293-60DDiscontinued by firm2026-07-31
excluded packagepackage49999-29349999-293-90DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075828-001LOVASTATINLOVASTATIN10MGTABLET / ORALAB2001-12-17
A075828-002LOVASTATINLOVASTATIN20MGTABLET / ORALAB2001-12-17
A075828-003LOVASTATINLOVASTATIN40MGTABLET / ORALAB2001-12-17

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A075828-001AB
A075828-002AB
A075828-003AB

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-293-30EA - Each49999-29351b8fd2f-4f58-4747-8c8c-4fa69b64032212013-06-04
49999-293-60EA - Each49999-293ee903120-9078-4d9a-9e41-42389b6c01da12013-09-04
49999-293-90EA - Each49999-29380564a46-bb05-4b5e-ba28-b5c7a14a41e612013-09-04

DailyMed Socrata Ingredients#