Home NDC 84386-034 Pravastatin sodium
Product NDC 84386-034
11-digit product format 843860034
Labeler code 84386
Product ID 84386-034_c21d4797-d252-4073-891f-330484c5f643
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pravastatin sodium
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA077793
Marketing category ANDA
Marketing start 2025-02-27
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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077793-001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077793-001 AB
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 2 · 43 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 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 84386-034-90 Pravastatin sodium 90 in 1 BOTTLE TABLET 90 1 84386-034-99 Pravastatin sodium 1000 in 1 BOTTLE TABLET 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84386-034 PRAVASTATIN SODIUM TABLET [AUROBINDO PHARMA LIMITED] 1 Current NDC, 2 package rows 20250302_c21d4797-d252-4073-891f-330484c5f643.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 · 2 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 84386-034-90 84386003490 90 TABLET in 1 BOTTLE (84386-034-90) 90 tablet 2025-02-27 No No Current 84386-034-99 84386003499 1000 TABLET in 1 BOTTLE (84386-034-99) 1000 tablet 2025-02-27 No No Current