Pravastatin sodium

Product NDC
51407-889
Requested package NDC
51407-889-90
11-digit product format
514070889
Labeler code
51407
Product ID
51407-889_4fffe2bf-0a75-d9a0-e063-6294a90a958f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA209869
Marketing category
ANDA
Marketing start
2018-04-13
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
2027-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Pravastatin sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3M8608UQ61Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
904458Internal RxNorm lookup
904467Internal RxNorm lookup
904475Internal RxNorm lookup
904481Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
25b7276e-a69f-af63-e063-6394a90aecf2Available on FDA.report

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
51407-889-10Pravastatin sodium1000 in 1 BOTTLETABLET10003
51407-889-90Pravastatin sodium90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-889-10EA - Each51407-889ad2ff2d5-4cb2-42ce-8a45-75ee25e59a9f12024-12-10
51407-889-90EA - Each51407-889b93acb98-057d-485c-8d9c-2abe3aca5a3d12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-889PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, 2 package rows20250424_25b7276e-a69f-af63-e063-6394a90aecf2.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
ndc (package): 51407-889-90
ndc (product): 51407-889
ndc11 (package): 51407088990
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 TabletPSN25b7276e-a69f-af63-e063-6394a90aecf23
904467pravastatin sodium 20 MG Oral TabletPSN25b7276e-a69f-af63-e063-6394a90aecf23
904475pravastatin sodium 40 MG Oral TabletPSN25b7276e-a69f-af63-e063-6394a90aecf23
904481pravastatin sodium 80 MG Oral TabletPSN25b7276e-a69f-af63-e063-6394a90aecf23
904458pravastatin sodium 10 MG Oral TabletSCD25b7276e-a69f-af63-e063-6394a90aecf23
904467pravastatin sodium 20 MG Oral TabletSCD25b7276e-a69f-af63-e063-6394a90aecf23
904475pravastatin sodium 40 MG Oral TabletSCD25b7276e-a69f-af63-e063-6394a90aecf23
904481pravastatin sodium 80 MG Oral TabletSCD25b7276e-a69f-af63-e063-6394a90aecf23
904475pravastatin sodium 40 MG Oral TabletPSN308db0cc-0deb-99b6-e063-6394a90a9b741
904475pravastatin sodium 40 MG Oral TabletSCD308db0cc-0deb-99b6-e063-6394a90a9b741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-889-905140708899090 TABLET in 1 BOTTLE (51407-889-90) 90 tablet2024-10-28NoNoCurrent