Home NDC 67544-245 Lovastatin
Product NDC 67544-245
11-digit product format 675440245
Labeler code 67544
Product ID 67544-245_0c57c932-2720-4ab0-8ae4-24983c75130b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lovastatin
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA075636
Marketing category ANDA
Marketing start 2001-12-17
Marketing end 2021-05-31
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 0000-00-00
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 A075636-001 LOVASTATIN LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 A075636-002 LOVASTATIN LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 A075636-003 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 A075636-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 a50c72e98297…2026-08-01 22:54:32 2026-06 A075636-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 a50c72e98297…2026-08-01 22:54:32 2026-06 A075636-003 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 [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 LOVASTATIN ACTIVE MOIETY 9LHU78OQFD LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67544-245-30 67544024530 30 TABLET in 1 BOTTLE, PLASTIC (67544-245-30) 30 tablet 2004-09-24 2021-05-31 No No Current 67544-245-60 67544024560 90 TABLET in 1 BOTTLE, PLASTIC (67544-245-60) 90 tablet 2004-08-17 2021-05-31 No No Current