Home NDC 70518-1938 PRAVASTATIN SODIUM
Product NDC 70518-1938
11-digit product format 705181938
Labeler code 70518
Product ID 70518-1938_5992f12f-b7b1-692d-e063-6394a90ae8e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PRAVASTATIN SODIUM
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA076341
Marketing category ANDA
Marketing start 2019-03-06
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 2027-12-31
Current FDA listing Yes 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 · 11 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A076341-001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 A076341-002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 A076341-003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 A076341-004 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 · 176 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 2026-10-15 13:18:30 2026-09 A076341-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076341-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076341-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076341-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076341-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076341-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076341-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076341-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076341-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076341-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076341-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076341-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076341-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076341-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076341-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076341-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076341-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076341-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076341-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076341-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076341-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076341-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076341-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076341-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076341-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076341-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076341-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076341-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076341-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076341-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076341-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076341-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076341-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076341-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076341-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076341-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076341-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076341-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076341-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076341-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 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 PRAVASTATIN SODIUM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAVASTATIN SODIUM 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3M8608UQ61 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 904467 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 70518-1938-0 2023-03-07 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-0 2023-03-07 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-0 2023-03-07 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-0 2023-03-07 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-0 2023-03-07 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-0 2023-03-07 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-1 2023-03-07 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-1 2023-03-07 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-1 2023-03-07 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-1 2023-03-07 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-1 2023-03-07 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-1 2023-03-07 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-0 2023-01-30 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-0 2023-01-30 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-0 2023-01-30 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-0 2023-01-30 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-0 2023-01-30 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-0 2023-01-30 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-1 2023-01-30 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-1 2023-01-30 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-1 2023-01-30 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-1 2023-01-30 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-1 2023-01-30 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991 70518-1938-1 2023-01-30 These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-1938-0 PRAVASTATIN SODIUM 30 in 1 BLISTER PACK TABLET 30 13 70518-1938-1 PRAVASTATIN SODIUM 90 in 1 BOTTLE, PLASTIC TABLET 90 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-1938 PRAVASTATIN SODIUM TABLET [REMEDYREPACK INC.] 9 Current NDC, Legacy NDC, 2 package rows 20250303_e4dbaa72-7b3e-4aef-983b-90efb2b343cd.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 3 of 3 · 42 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 70518-1938-0 70518193800 30 TABLET in 1 BLISTER PACK (70518-1938-0) 30 tablet 2019-03-06 0000-00-00 No No Current 70518-1938-1 70518193801 90 TABLET in 1 BOTTLE, PLASTIC (70518-1938-1) 90 tablet 2019-04-30 0000-00-00 No No Current