Home NDC 45963-635 Lovastatin
Product NDC 45963-635
11-digit product format 459630635
Labeler code 45963
Product ID 45963-635_fa0b909d-8e24-416d-9674-b18bb436e657
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lovastatin
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA075828
Marketing category ANDA
Marketing start 2001-12-17
Marketing end 2021-03-31
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 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 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 [ACTAVIS INC.] 12 LOVASTATIN ACTIVE MOIETY 9LHU78OQFD LOVASTATIN TABLET [ACTAVIS INC.] 12 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U LOVASTATIN TABLET [ACTAVIS INC.] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOVASTATIN TABLET [ACTAVIS INC.] 12 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B LOVASTATIN TABLET [ACTAVIS INC.] 12 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOVASTATIN TABLET [ACTAVIS INC.] 12 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOVASTATIN TABLET [ACTAVIS INC.] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOVASTATIN TABLET [ACTAVIS INC.] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOVASTATIN TABLET [ACTAVIS INC.] 12 LOVASTATIN ACTIVE INGREDIENT 9LHU78OQFD LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 LOVASTATIN ACTIVE MOIETY 9LHU78OQFD LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 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 45963-635-01 45963063501 60 TABLET in 1 BOTTLE (45963-635-01) 60 tablet 2011-09-26 2021-02-28 No No Current 45963-635-04 45963063504 500 TABLET in 1 BOTTLE (45963-635-04) 500 tablet 2001-12-17 2021-03-31 No No Current