PRAVASTATIN SODIUM

Product NDC
63629-8905
Requested package NDC
63629-8905-1
11-digit product format
636298905
Labeler code
63629
Product ID
63629-8905_336646eb-801f-7b28-e063-6294a90ab91e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209869
Marketing category
ANDA
Marketing start
2021-02-01
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
2026-12-31
Current FDA listing
Yes

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 packagepackage63629-890563629-8905-1DDiscontinued by firm2026-08-03

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
A209869-001PRAVASTATIN SODIUMPRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-13
A209869-002PRAVASTATIN SODIUMPRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-13
A209869-003PRAVASTATIN SODIUMPRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-13
A209869-004PRAVASTATIN SODIUMPRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209869-001AB
A209869-002AB
A209869-003AB
A209869-004AB

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 UTC2026-02A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-13d06236e962d9…

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 UTC2026-02A209869-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209869-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209869-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209869-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209869-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209869-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209869-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209869-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209869-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209869-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209869-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209869-004AB1d06236e962d9…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
36361c23-a766-1581-d616-2080c781a50cProduct name520190314
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8905-1PRAVASTATIN SODIUM1000 in 1 BOTTLETABLET1000103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8905-1EA - Each63629-8905878fa6c3-8195-4a62-bb02-5586535cef0612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8905PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20250424_489c70a9-e574-4520-a0c0-70b7e0d87838.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackca7a4143-0091-4cd5-9061-cb05cc84ea4e2026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepackf074240e-ef6b-45f2-8c4d-cb5c0dbc81f12026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack3686a2df-51c4-4f1c-9d1e-d692079151442026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackd0641def-425e-4357-a6b6-24ce004245492026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackdcf46d0c-87da-4009-b238-eb5cf287c3ed2026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMGolden State Medical Supply, Inc.25b7276e-a69f-af63-e063-6394a90aecf22026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMBiocon Pharma Inc.9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb2026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions2f658680-939a-4212-8a5e-a44a896dd2212026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions3b9fe7c9-791e-49a0-a005-ccf13036c3652026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMNorthwind Health Company, LLC40aa2d36-57ce-1f48-e063-6294a90affef2026-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMNorthwind Health Company, LLC47207487-0c6d-8da3-e063-6294a90a8aee2025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack4ed7a4d1-1183-4d95-8311-6d3e58feafa82025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack91c5b5c8-3379-4b84-aff7-ef6cfc65fe9f2025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions33c141e9-76dc-4e32-9b2a-4621f32ac4bd2025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions72693449-01ee-42b0-9902-5662523245792025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack7b7f5c28-78fa-4625-ad69-4291500e033d2025-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack51800012-406b-4389-817f-88dd21e338d12025-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepacka7f75948-2958-44c8-b52f-5e39e80cdd1f2025-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepacke358f314-9cbe-46a4-9564-6bedc7ef9d592025-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack80ddec55-6a18-4b87-8a07-6ae86ad628532025-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN489c70a9-e574-4520-a0c0-70b7e0d87838103
904458pravastatin sodium 10 MG Oral TabletSCD489c70a9-e574-4520-a0c0-70b7e0d87838103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8905-1636298905011000 TABLET in 1 BOTTLE (63629-8905-1) 1000 tablet2021-11-190000-00-00NoNoCurrent