Home NDC 43063-143 Pravastatin sodium
Product NDC 43063-143
11-digit product format 430630143
Labeler code 43063
Product ID 43063-143_d2960d2a-3f29-c205-e053-2a95a90a1500
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pravastatin sodium
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA076714
Marketing category ANDA
Marketing start 2009-12-31
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 2022-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43063-143-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43063-143-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43063-143-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43063-143-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43063-143-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43063-143-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43063-143-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43063-143-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43063-143-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43063-143-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43063-143-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43063-143-30 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A076714-001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 A076714-002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 A076714-003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 A076714-004 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 · 168 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 2026-08-18 06:07:40 2026-07 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAVASTATIN SODIUM ACTIVE INGREDIENT 3M8608UQ61 PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 1 PRAVASTATIN ACTIVE MOIETY KXO2KT9N0G PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 1 MEGLUMINE INACTIVE INGREDIENT 6HG8UB2MUY PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 1
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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43063-143-30 43063014330 30 TABLET in 1 BOTTLE, PLASTIC (43063-143-30) 30 tablet 2012-04-02 0000-00-00 No No Current