Home NDC 71335-0947 PRAVASTATIN SODIUM
Product NDC 71335-0947
11-digit product format 713350947
Labeler code 71335
Product ID 71335-0947_eaf669a7-a5e3-4241-aed5-f696283508e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PRAVASTATIN SODIUM
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA077917
Marketing category ANDA
Marketing start 2008-07-24
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 2026-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A077917-001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 A077917-002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 A077917-003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 A077917-004 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08
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 · 164 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 2026-02-19 14:30 UTC 2026-02 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PRAVASTATIN SODIUM
Listing expiration 2026-12-31 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 71335-0947-1 2024-05-21 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 71335-0947-2 2024-05-21 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 71335-0947-3 2024-05-21 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 71335-0947-4 2024-05-21 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 71335-0947-5 2024-05-21 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 71335-0947-1 2024-01-30 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 71335-0947-2 2024-01-30 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 71335-0947-3 2024-01-30 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 71335-0947-4 2024-01-30 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 71335-0947-5 2024-01-30 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 71335-0947-1 PRAVASTATIN SODIUM 30 in 1 BOTTLE TABLET 30 7 71335-0947-2 PRAVASTATIN SODIUM 90 in 1 BOTTLE TABLET 90 7 71335-0947-3 PRAVASTATIN SODIUM 100 in 1 BOTTLE TABLET 100 7 71335-0947-4 PRAVASTATIN SODIUM 60 in 1 BOTTLE TABLET 60 7 71335-0947-5 PRAVASTATIN SODIUM 10 in 1 BOTTLE TABLET 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0947 PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK] 7 Current NDC, Legacy NDC, 5 package rows 20240522_24471777-5cd6-4c46-a5f2-a349fadc830e.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 1 of 1 · 3 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 71335-0947-1 71335094701 30 TABLET in 1 BOTTLE (71335-0947-1) 30 tablet 2022-09-23 0000-00-00 No No Current 71335-0947-2 71335094702 90 TABLET in 1 BOTTLE (71335-0947-2) 90 tablet 2018-09-04 0000-00-00 No No Current 71335-0947-3 71335094703 100 TABLET in 1 BOTTLE (71335-0947-3) 100 tablet 2022-09-23 0000-00-00 No No Current 71335-0947-4 71335094704 60 TABLET in 1 BOTTLE (71335-0947-4) 60 tablet 2022-09-23 0000-00-00 No No Current 71335-0947-5 71335094705 10 TABLET in 1 BOTTLE (71335-0947-5) 10 tablet 2022-09-23 0000-00-00 No No Current