Home NDC 57237-165-05 Pravastatin sodium
Product NDC 57237-165
Requested package NDC 57237-165-05
11-digit product format 572370165
Labeler code 57237
Product ID 57237-165_e5ef567c-556d-4df2-a369-b0e7cd1058b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pravastatin sodium
Dosage form TABLET
Route ORAL
Labeler Rising Health, LLC
Application ANDA203367
Marketing category ANDA
Marketing start 2017-02-02
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A203367-001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2017-02-02 A203367-002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2017-02-02 A203367-003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2017-02-02 A203367-004 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2017-02-02
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 · 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 A203367-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2017-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203367-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2017-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203367-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2017-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203367-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2017-02-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203367-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2017-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203367-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2017-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203367-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2017-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203367-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2017-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203367-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2017-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203367-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2017-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203367-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2017-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203367-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2017-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203367-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2017-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203367-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2017-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203367-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2017-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203367-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2017-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203367-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2017-02-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203367-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2017-02-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203367-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2017-02-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203367-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2017-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203367-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2017-02-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203367-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2017-02-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203367-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2017-02-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203367-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2017-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203367-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2017-02-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203367-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2017-02-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203367-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2017-02-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203367-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2017-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203367-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2017-02-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203367-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2017-02-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203367-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2017-02-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203367-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2017-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203367-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2017-02-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203367-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2017-02-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203367-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2017-02-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203367-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2017-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203367-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2017-02-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203367-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2017-02-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203367-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2017-02-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203367-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2017-02-02 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 57237-165-05 57237016505 500 TABLET in 1 BOTTLE (57237-165-05) 500 tablet 2017-02-02 0000-00-00 No No Current