Home NDC 60429-402 Lovastatin
Product NDC 60429-402
11-digit product format 604290402
Labeler code 60429
Product ID 60429-402_c9eebb1d-94dd-dd54-e053-2a95a90a9a0c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lovastatin
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA075828
Marketing category ANDA
Marketing start 2001-12-17
Marketing end 0000-00-00
Substance LOVASTATIN
Active strength 40 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 RLD / RS 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.
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 RLD / RS 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOVASTATIN ACTIVE INGREDIENT 9LHU78OQFD LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 LOVASTATIN ACTIVE MOIETY 9LHU78OQFD LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60429-402-10 60429040210 1000 TABLET in 1 BOTTLE (60429-402-10) 1000 tablet 2014-06-24 2021-03-31 No No Current 60429-402-60 60429040260 60 TABLET in 1 BOTTLE (60429-402-60) 60 tablet 2014-06-24 2021-03-31 No No Current 60429-402-90 60429040290 90 TABLET in 1 BOTTLE (60429-402-90) 90 tablet 2014-06-24 0000-00-00 No No Current