Lovastatin

Product NDC
70518-0206
11-digit product format
705180206
Labeler code
70518
Product ID
70518-0206_82d1c92b-33f9-d39c-e053-2a91aa0ad846
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075828
Marketing category
ANDA
Marketing start
2017-02-08
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
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 productproduct70518-0206DDiscontinued by firm2026-07-31
excluded packagepackage70518-020670518-0206-0DDiscontinued 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