Home NDC 50268-668 PRAVASTATIN SODIUM
Product NDC 50268-668
11-digit product format 502680668
Labeler code 50268
Product ID 50268-668_47fb4c90-456b-508c-e063-6394a90a5da5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PRAVASTATIN SODIUM
Dosage form TABLET
Route ORAL
Labeler AvPAK
Application ANDA076341
Marketing category ANDA
Marketing start 2021-02-01
Substance PRAVASTATIN SODIUM
Active strength 80 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 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 80 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 50268-668-11 PRAVASTATIN SODIUM 1 in 1 BLISTER PACK TABLET 1 6 50268-668-12 PRAVASTATIN SODIUM 20 in 1 BOX TABLET 20 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-668 PRAVASTATIN SODIUM TABLET [AVPAK] 5 Current NDC, Legacy NDC, 2 package rows 20240110_ba4ac602-46fa-8386-e053-2995a90a9764.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 50268-668-11 50268066811 1 in 1 BLISTER PACK Historical 50268-668-12 50268066812 20 BLISTER PACK in 1 BOX (50268-668-12) / 1 TABLET in 1 BLISTER PACK (50268-668-11) 20 blister pack 2021-02-01 0000-00-00 No No Current 50268-668-15 50268066815 50 BLISTER PACK in 1 BOX (50268-668-15) > 1 TABLET in 1 BLISTER PACK (50268-668-11) 50 blister pack 2021-02-01 0000-00-00 No No Current