Pravastatin sodium

Product NDC
48433-148
11-digit product format
484330148
Labeler code
48433
Product ID
48433-148_49ef1f35-49ba-be39-e063-6394a90a9c8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Safecor Health LLC
Application
ANDA076056
Marketing category
ANDA
Marketing start
2026-01-28
Substance
PRAVASTATIN SODIUM
Active strength
20 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076056-001PRAVASTATIN SODIUMPRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-24
A076056-002PRAVASTATIN SODIUMPRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-24
A076056-003PRAVASTATIN SODIUMPRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076056-001AB
A076056-002AB
A076056-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076056-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076056-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076056-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076056-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076056-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076056-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076056-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076056-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076056-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076056-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076056-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076056-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076056-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076056-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076056-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076056-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076056-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076056-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A076056-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A076056-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076056-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076056-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076056-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076056-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076056-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076056-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076056-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-04-248072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076056-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076056-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076056-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076056-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076056-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076056-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076056-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076056-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076056-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076056-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076056-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076056-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076056-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076056-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076056-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076056-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076056-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076056-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076056-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076056-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076056-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076056-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076056-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076056-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076056-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076056-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076056-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076056-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076056-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076056-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076056-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076056-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076056-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076056-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076056-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076056-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076056-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076056-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076056-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076056-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM20 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 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ae196a4-be3d-4cd8-9ff2-68aeb91b8678Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36361c23-a766-1581-d616-2080c781a50cProduct name520190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-148-01Pravastatin sodium1 in 1 BLISTER PACKTABLET14
48433-148-20Pravastatin sodium100 in 1 CARTONTABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-148-20EA - Each48433-148bb0214b8-1402-42bc-b7d0-680a1bc69fbe12026-05-22

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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pravastatin SodiumPRAVASTATIN SODIUMREMEDYREPACK INC.0c4b59f1-92a8-44f8-8b4c-691f357774602026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin SodiumPRAVASTATIN SODIUMCardinal Health 107, LLCca779f66-4b9d-41da-ad0e-e4f58db9fbac2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin sodiumPRAVASTATIN SODIUMSafecor Health LLC0ae196a4-be3d-4cd8-9ff2-68aeb91b86782026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
ndc (product): 48433-148
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutionsb7f8c679-a602-4268-81b6-962a136a4e432026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions8df47d82-5b09-414d-99f1-7ac4c77f7c012026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin SodiumPRAVASTATIN SODIUMNorthwind Health Company, LLCf6ddb6c0-d0b4-2297-e053-6294a90a83c92026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin sodiumPRAVASTATIN SODIUMNorthwind Health Company, LLC471b4dac-057d-740c-e063-6294a90af9e92025-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin sodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.f92e12bc-40c3-4afa-9190-2f4de11ec6b32025-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin sodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.e6a3d99c-c9cc-49d9-b0f9-503770307b702025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin sodiumPRAVASTATIN SODIUMNuCare Pharmaceuticals, Inc.3ef390a6-e0a0-331d-e063-6394a90a83d02025-10-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin sodiumPRAVASTATIN SODIUMREMEDYREPACK INC.fa152ce7-6c07-4aaf-9374-932ce81d0cf92025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin sodiumPRAVASTATIN SODIUMREMEDYREPACK INC.6cef5e92-26b7-435c-878f-72a05a6245602025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin SodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.7abc1825-182d-40bc-9f7f-968e197b42462025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin SodiumPRAVASTATIN SODIUMMylan Institutional Inc.1b00f510-c86d-46f6-b427-311a8fd149552025-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin sodiumPRAVASTATIN SODIUMAurobindo Pharma Limitedcf6f7031-33b9-40d3-bc87-32f1b6af98f22025-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin SodiumPRAVASTATIN SODIUMNuCare Pharmaceuticals, Inc.2d40e473-f79a-e50e-e063-6294a90a4d9e2025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions55f8cf43-bf8b-4729-9e5a-32fcc9696e022024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin SodiumPRAVASTATIN SODIUMTeva Pharmaceuticals USA, Inc.99e0e848-f8f3-4b42-b880-8fbc426339482024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions4f9ada33-5592-4780-926d-1af49a8e064e2023-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056
Pravastatin SodiumPRAVASTATIN SODIUMProficient Rx LP466e2d1a-a6d6-40f8-a9f6-3e7494a34ca62023-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076056
application number: ANDA076056

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN0ae196a4-be3d-4cd8-9ff2-68aeb91b86784
904475pravastatin sodium 40 MG Oral TabletPSN0ae196a4-be3d-4cd8-9ff2-68aeb91b86784
904467pravastatin sodium 20 MG Oral TabletSCD0ae196a4-be3d-4cd8-9ff2-68aeb91b86784
904475pravastatin sodium 40 MG Oral TabletSCD0ae196a4-be3d-4cd8-9ff2-68aeb91b86784

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-148-01484330148011 in 1 BLISTER PACKHistorical
48433-148-2048433014820100 BLISTER PACK in 1 CARTON (48433-148-20) / 1 TABLET in 1 BLISTER PACK (48433-148-01) 100 blister pack2026-01-28NoNoCurrent