Pravastatin Sodium

Product NDC
70518-2505
11-digit product format
705182505
Labeler code
70518
Product ID
70518-2505_4e01137e-8d3a-fd36-e063-6294a90a4363
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076056
Marketing category
ANDA
Marketing start
2019-12-24
Marketing end
2026-09-30
Substance
PRAVASTATIN SODIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2505DDiscontinued by firm2026-08-03
excluded packagepackage70518-250570518-2505-0DDiscontinued by firm2026-08-03
excluded packagepackage70518-250570518-2505-1DDiscontinued by firm2026-08-03

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 · 1 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 packagepackage70518-250570518-2505-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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…

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
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 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
70518-2505-0Pravastatin Sodium30 in 1 BLISTER PACKTABLET3011
70518-2505-1Pravastatin Sodium90 in 1 BOTTLE, PLASTICTABLET9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2505PRAVASTATIN SODIUM TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 2 package rows20250319_7e400611-7432-4911-8662-1f0a740f76bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSN7e400611-7432-4911-8662-1f0a740f76bb11
904475pravastatin sodium 40 MG Oral TabletSCD7e400611-7432-4911-8662-1f0a740f76bb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2505-07051825050030 TABLET in 1 BLISTER PACK (70518-2505-0) 30 tablet2019-12-240000-00-00NoNoCurrent
70518-2505-17051825050190 TABLET in 1 BOTTLE, PLASTIC (70518-2505-1) 90 tablet2021-01-120000-00-00NoNoCurrent