pravastatin sodium

Product NDC
63629-4588
Requested package NDC
63629-4588-3
11-digit product format
636294588
Labeler code
63629
Product ID
63629-4588_de916393-2e70-492c-9fe4-1158187efe9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077751
Marketing category
ANDA
Marketing start
2010-03-30
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-458863629-4588-3DDiscontinued by firm2026-10-05

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 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077751-001PRAVASTATIN SODIUMPRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30
A077751-002PRAVASTATIN SODIUMPRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30
A077751-003PRAVASTATIN SODIUMPRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30
A077751-004PRAVASTATIN SODIUMPRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077751-002AB
A077751-003AB
A077751-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-3084e616aacf4f…
2026-08-18 06:07:402026-07A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-305bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 133 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077751-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077751-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077751-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A077751-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077751-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077751-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077751-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077751-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077751-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077751-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077751-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077751-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077751-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077751-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077751-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077751-002AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6OPRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4588-36362945880310 TABLET in 1 BOTTLE (63629-4588-3) 10 tablet2022-02-080000-00-00NoNoCurrent