Home NDC 69292-101 Pravastatin Sodium
Product NDC 69292-101
11-digit product format 692920101
Labeler code 69292
Product ID 69292-101_52351ef8-7a5a-6e07-e063-6294a90af72a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pravastatin Sodium
Dosage form TABLET
Route ORAL
Labeler Amici Pharma, Inc.
Application ANDA077491
Marketing category ANDA
Marketing start 2026-05-19
Substance PRAVASTATIN SODIUM
Active strength 10 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 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 A077491-001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-02-11 A077491-002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 A077491-003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 A077491-004 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23
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 4 · 152 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 A077491-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077491-002 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077491-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077491-004 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077491-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077491-002 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077491-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077491-004 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077491-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077491-002 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077491-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077491-004 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077491-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077491-002 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077491-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077491-004 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077491-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077491-002 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077491-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077491-004 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077491-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077491-002 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077491-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077491-004 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077491-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077491-002 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077491-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077491-004 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077491-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077491-002 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077491-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077491-004 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077491-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-02-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077491-002 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077491-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077491-004 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077491-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-02-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077491-002 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077491-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077491-004 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 152 observed states.
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 10 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 904458 Internal RxNorm lookup 904467 Internal RxNorm lookup 904475 Internal RxNorm lookup 904481 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69292-101-10 Pravastatin Sodium 1000 in 1 BOTTLE TABLET 1000 2 69292-101-50 Pravastatin Sodium 500 in 1 BOTTLE TABLET 500 2 69292-101-90 Pravastatin Sodium 90 in 1 BOTTLE TABLET 90 2
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69292-101-10 69292010110 1000 TABLET in 1 BOTTLE (69292-101-10) 1000 tablet 2026-05-19 No No Current 69292-101-50 69292010150 500 TABLET in 1 BOTTLE (69292-101-50) 500 tablet 2026-05-19 No No Current 69292-101-90 69292010190 90 TABLET in 1 BOTTLE (69292-101-90) 90 tablet 2026-05-19 No No Current