Home NDC 0093-7270 Pravastatin Sodium
Product NDC 0093-7270
11-digit product format 000937270
Labeler code 0093
Product ID 0093-7270_5dc51036-2891-4ba5-8032-210745fd125a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pravastatin Sodium
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA077793
Marketing category ANDA
Marketing start 2008-09-29
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 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 2 · 69 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 · 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 · 41 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 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077793-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB RS 2008-01-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAVASTATIN SODIUM ACTIVE INGREDIENT 3M8608UQ61 PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 PRAVASTATIN ACTIVE MOIETY KXO2KT9N0G PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 PRAVASTATIN SODIUM ACTIVE INGREDIENT 3M8608UQ61 PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1 PRAVASTATIN ACTIVE MOIETY KXO2KT9N0G PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 1
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 Marketing end Sample Exclude flag Status 0093-7270-10 00093727010 1000 TABLET in 1 BOTTLE (0093-7270-10) 1000 tablet 2008-09-29 0000-00-00 No No Current 0093-7270-98 00093727098 90 TABLET in 1 BOTTLE (0093-7270-98) 90 tablet 2008-09-29 0000-00-00 No No Current