Home NDC 68180-467 Lovastatin
Product NDC 68180-467
11-digit product format 681800467
Labeler code 68180
Product ID 68180-467_ebd1b7a8-bc2e-4f09-99b0-1e46a971d4f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lovastatin
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA078296
Marketing category ANDA
Marketing start 2008-03-14
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A078296-001 LOVASTATIN LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 A078296-002 LOVASTATIN LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 A078296-003 LOVASTATIN LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01
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.
Product history page 1 of 4 · 129 observed 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 2026-09-14 22:38:34 2026-08 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lovastatin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOVASTATIN 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9LHU78OQFD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197903 Internal RxNorm lookup 197904 Internal RxNorm lookup 197905 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOVASTATIN ACTIVE INGREDIENT 9LHU78OQFD LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] 7 LOVASTATIN ACTIVE MOIETY 9LHU78OQFD LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] 7 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] 7 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] 7 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] 7 LOVASTATIN ACTIVE INGREDIENT 9LHU78OQFD LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.] 5 LOVASTATIN ACTIVE MOIETY 9LHU78OQFD LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.] 5 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.] 5 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.] 5 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.] 5 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.] 5 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.] 5 LOVASTATIN ACTIVE INGREDIENT 9LHU78OQFD LOVASTATIN TABLET [DIRECT RX] 2 LOVASTATIN ACTIVE MOIETY 9LHU78OQFD LOVASTATIN TABLET [DIRECT RX] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LOVASTATIN TABLET [DIRECT RX] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U LOVASTATIN TABLET [DIRECT RX] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOVASTATIN TABLET [DIRECT RX] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOVASTATIN TABLET [DIRECT RX] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LOVASTATIN TABLET [DIRECT RX] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOVASTATIN TABLET [DIRECT RX] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOVASTATIN TABLET [DIRECT RX] 2 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ LOVASTATIN TABLET [DIRECT RX] 2 LOVASTATIN ACTIVE INGREDIENT 9LHU78OQFD LOVASTATIN TABLET [STAT RX USA LLC] 1 LOVASTATIN ACTIVE INGREDIENT 9LHU78OQFD LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] 1 LOVASTATIN ACTIVE INGREDIENT 9LHU78OQFD LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 LOVASTATIN ACTIVE MOIETY 9LHU78OQFD LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] 1 LOVASTATIN ACTIVE MOIETY 9LHU78OQFD LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 LOVASTATIN ACTIVE MOIETY 9LHU78OQFD LOVASTATIN TABLET [STAT RX USA LLC] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LOVASTATIN TABLET [STAT RX USA LLC] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U LOVASTATIN TABLET [STAT RX USA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOVASTATIN TABLET [STAT RX USA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOVASTATIN TABLET [STAT RX USA LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LOVASTATIN TABLET [STAT RX USA LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOVASTATIN TABLET [STAT RX USA LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOVASTATIN TABLET [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] 1 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ LOVASTATIN TABLET [STAT RX USA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-467 LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.] 14 Current NDC, Legacy NDC, 5 package rows 20231102_df7ddf4f-d569-431e-81f1-9129d7043150.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 2 of 2 · 21 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-467-01 68180046701 100 TABLET in 1 BOTTLE (68180-467-01) 100 tablet 2008-03-14 0000-00-00 No No Current 68180-467-03 68180046703 1000 TABLET in 1 BOTTLE (68180-467-03) 1000 tablet 2008-03-14 0000-00-00 No No Current 68180-467-05 68180046705 5000 TABLET in 1 BOTTLE (68180-467-05) 5000 tablet 2008-03-14 0000-00-00 No No Current 68180-467-07 68180046707 60 TABLET in 1 BOTTLE (68180-467-07) 60 tablet 2008-03-14 0000-00-00 No No Current 68180-467-09 68180046709 90 TABLET in 1 BOTTLE (68180-467-09) 90 tablet 2019-06-04 0000-00-00 No No Current