PRAVASTATIN SODIUM

Product NDC
63629-7086
Requested package NDC
63629-7086-1
11-digit product format
636297086
Labeler code
63629
Product ID
63629-7086_2abc4689-42f7-4641-9196-7e1dbdd9f64c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077491
Marketing category
ANDA
Marketing start
2014-07-28
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
2021-12-31
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 packagepackage63629-708663629-7086-1DDiscontinued by firm2026-08-11

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077491-001PRAVASTATIN SODIUMPRAVASTATIN SODIUM80MGTABLET / ORALAB2008-02-11
A077491-002PRAVASTATIN SODIUMPRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23
A077491-003PRAVASTATIN SODIUMPRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23
A077491-004PRAVASTATIN SODIUMPRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A077491-001AB
A077491-002AB
A077491-003AB
A077491-004AB

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 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077491-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077491-002PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077491-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077491-004PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077491-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077491-002PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077491-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077491-004PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077491-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077491-002PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077491-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077491-004PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077491-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077491-002PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077491-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077491-004PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077491-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077491-002PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077491-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077491-004PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077491-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077491-002PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077491-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077491-004PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077491-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077491-002PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077491-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077491-004PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077491-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077491-002PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077491-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077491-004PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077491-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077491-002PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077491-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077491-004PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077491-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077491-002PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A077491-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A077491-004PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077491-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077491-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077491-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077491-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077491-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077491-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077491-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077491-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077491-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077491-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077491-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077491-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077491-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077491-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077491-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077491-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077491-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077491-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077491-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077491-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077491-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077491-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077491-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077491-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077491-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077491-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077491-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077491-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077491-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077491-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077491-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077491-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077491-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077491-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077491-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077491-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077491-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077491-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077491-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077491-004AB1d06236e962d9…

FDA-Initiated Inactive NDC Indexing#

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pravastatin SodiumPRAVASTATIN SODIUMAmici Pharma, Inc.e6551230-fe4c-4a6e-9c19-ae9945b76db02026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077491
application number: ANDA077491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7086-16362970860130 TABLET in 1 BOTTLE (63629-7086-1) 30 tablet2016-09-160000-00-00NoNoCurrent