Pravastatin sodium

Product NDC
63187-732
Requested package NDC
63187-732-30
11-digit product format
631870732
Labeler code
63187
Product ID
63187-732_34dcede0-61f8-4aaa-b409-0e7d5c9e6f02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076939
Marketing category
ANDA
Marketing start
2006-10-23
Marketing end
0000-00-00
Substance
PRAVASTATIN SODIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage63187-73263187-732-30DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-73263187-732-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-73263187-732-30DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A076939-001PRAVASTATIN SODIUMPRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28
A076939-002PRAVASTATIN SODIUMPRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23
A076939-003PRAVASTATIN SODIUMPRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23
A076939-004PRAVASTATIN SODIUMPRAVASTATIN SODIUM10MGTABLET / 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
A076939-001AB
A076939-002AB
A076939-003AB
A076939-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076939-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076939-002PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076939-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076939-004PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076939-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076939-002PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076939-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076939-004PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076939-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076939-002PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076939-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076939-004PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076939-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076939-002PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076939-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076939-004PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076939-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076939-002PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076939-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076939-004PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076939-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076939-002PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076939-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076939-004PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076939-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076939-002PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076939-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076939-004PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076939-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076939-002PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076939-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076939-004PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076939-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076939-002PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076939-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076939-004PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076939-001PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A076939-002PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076939-003PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076939-004PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076939-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076939-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076939-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076939-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076939-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076939-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076939-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076939-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076939-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076939-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076939-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076939-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076939-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076939-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076939-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076939-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076939-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076939-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076939-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076939-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076939-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076939-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076939-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076939-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076939-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076939-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076939-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076939-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076939-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076939-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076939-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076939-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076939-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076939-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076939-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076939-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076939-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076939-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076939-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076939-004AB1d06236e962d9…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-732PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP]3Legacy NDC20191121_28b97a67-44d8-4db0-b166-60f096d409f5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-732-306318707323030 TABLET in 1 BOTTLE (63187-732-30) 30 tablet2016-07-010000-00-00NoNoCurrent