Home NDC 42291-669-90 Pravastatin Sodium
Product NDC 42291-669
Requested package NDC 42291-669-90
11-digit product format 422910669
Labeler code 42291
Product ID 42291-669_ec190869-82b8-6c7f-e053-2a95a90a8577
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pravastatin Sodium
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA077793
Marketing category ANDA
Marketing start 2014-06-30
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 2026-08-18 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…2022-09-29 23:25 UTC 2022-09 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAVASTATIN SODIUM ACTIVE INGREDIENT 3M8608UQ61 PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 PRAVASTATIN ACTIVE MOIETY KXO2KT9N0G PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 Ferric Oxide Red INACTIVE INGREDIENT 1K09F3G675 PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-669 PRAVASTATIN SODIUM TABLET [AVKARE] 12 Legacy NDC 20230913_345979e5-647b-7898-a933-e43a25250627.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-669-90 42291066990 90 TABLET in 1 BOTTLE (42291-669-90) 90 tablet 2014-06-30 0000-00-00 No No Current