Home NDC 68382-071-10 pravastatin sodium
Product NDC 68382-071
Requested package NDC 68382-071-10
11-digit product format 683820071
Labeler code 68382
Product ID 68382-071_12014495-c66a-407e-aa7b-5c58596230ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pravastatin sodium
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA077751
Marketing category ANDA
Marketing start 2010-03-30
Marketing end 0000-00-00
Substance PRAVASTATIN SODIUM
Active strength 20 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68382-071 68382-071-10 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68382-071 68382-071-10 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077751-001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET / ORAL 2008-04-30 A077751-002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-04-30 A077751-003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-04-30 A077751-004 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-04-30
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 5 · 172 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 A077751-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL 2008-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077751-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077751-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077751-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-04-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077751-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL 2008-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077751-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077751-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077751-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077751-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL 2008-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077751-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077751-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077751-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077751-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL 2008-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077751-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077751-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077751-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077751-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL 2008-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077751-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077751-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077751-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077751-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL 2008-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077751-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077751-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077751-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077751-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL 2008-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077751-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077751-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077751-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077751-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL 2008-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077751-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077751-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077751-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077751-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL 2008-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077751-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077751-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077751-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077751-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL 2008-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077751-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077751-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077751-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-04-30 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 133 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAVASTATIN SODIUM ACTIVE INGREDIENT 3M8608UQ61 PRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 PRAVASTATIN ACTIVE MOIETY KXO2KT9N0G PRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 POLYOXYL 35 CASTOR OIL INACTIVE INGREDIENT 6D4M1DAL6O PRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T PRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 PRAVASTATIN SODIUM ACTIVE INGREDIENT 3M8608UQ61 PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 PRAVASTATIN ACTIVE MOIETY KXO2KT9N0G PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 POLYOXYL 35 CASTOR OIL INACTIVE INGREDIENT 6D4M1DAL6O PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 PRAVASTATIN SODIUM ACTIVE INGREDIENT 3M8608UQ61 PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP] 2 PRAVASTATIN ACTIVE MOIETY KXO2KT9N0G PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP] 2 POLYOXYL 35 CASTOR OIL INACTIVE INGREDIENT 6D4M1DAL6O PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP] 2 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP] 2 PRAVASTATIN SODIUM ACTIVE INGREDIENT 3M8608UQ61 PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 PRAVASTATIN SODIUM ACTIVE INGREDIENT 3M8608UQ61 PRAVASTATIN SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC] 1 PRAVASTATIN SODIUM ACTIVE INGREDIENT 3M8608UQ61 PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PRAVASTATIN ACTIVE MOIETY KXO2KT9N0G PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PRAVASTATIN ACTIVE MOIETY KXO2KT9N0G PRAVASTATIN SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC] 1 PRAVASTATIN ACTIVE MOIETY KXO2KT9N0G PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 POLYOXYL 35 CASTOR OIL INACTIVE INGREDIENT 6D4M1DAL6O PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYOXYL 35 CASTOR OIL INACTIVE INGREDIENT 6D4M1DAL6O PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] 1
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 68382-071-10 68382007110 1000 TABLET in 1 BOTTLE (68382-071-10) 1000 tablet 2010-03-30 0000-00-00 No No Current