Pravastatin Sodium

Product NDC
0615-8158
11-digit product format
006158158
Labeler code
0615
Product ID
0615-8158_16e8c2ab-0669-4f92-a799-3700677af85b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravatatin
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA077987
Marketing category
ANDA
Marketing start
2018-07-10
Marketing end
0000-00-00
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
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-8158DDiscontinued by firm2026-08-03
excluded packagepackage0615-81580615-8158-39DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-8158-39d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-8158-39f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-8158-392ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-8158-39a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-8158-39cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-8158-39cdf11ea48f46…ba0047e9e063…

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
A077987-001PRAVASTATIN SODIUMPRAVASTATIN SODIUM10MGTABLET / ORALAB2007-05-11
A077987-002PRAVASTATIN SODIUMPRAVASTATIN SODIUM20MGTABLET / ORALAB2007-05-11
A077987-003PRAVASTATIN SODIUMPRAVASTATIN SODIUM40MGTABLET / ORALAB2007-05-11
A077987-004PRAVASTATIN SODIUMPRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077987-001AB
A077987-002AB
A077987-003AB
A077987-004AB

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 UTC2026-02A077987-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2007-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077987-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2007-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077987-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2007-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077987-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077987-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2007-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077987-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2007-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077987-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2007-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077987-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077987-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2007-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077987-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2007-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077987-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2007-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077987-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077987-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2007-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077987-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2007-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077987-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2007-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077987-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077987-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2007-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077987-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2007-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077987-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2007-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077987-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077987-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2007-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077987-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2007-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077987-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2007-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077987-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077987-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2007-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077987-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2007-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077987-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2007-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077987-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077987-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2007-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077987-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2007-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077987-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2007-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077987-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077987-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2007-05-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077987-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2007-05-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077987-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2007-05-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077987-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077987-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2007-05-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077987-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2007-05-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077987-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2007-05-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077987-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28d06236e962d9…

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 UTC2026-02A077987-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077987-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077987-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077987-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077987-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077987-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077987-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077987-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077987-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077987-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077987-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077987-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077987-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077987-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077987-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077987-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077987-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077987-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077987-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077987-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077987-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077987-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077987-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077987-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077987-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077987-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077987-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077987-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077987-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077987-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077987-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077987-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077987-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077987-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077987-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077987-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077987-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077987-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077987-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077987-004AB1d06236e962d9…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8158PRAVASTATIN SODIUM TABLET PRAVASTATIN SODIUM (PRAVATATIN) TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]14Legacy NDC20240802_5f7711ec-80c9-4c84-a139-ae2f7862d646.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 1 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAmerican Health Packaging97f826f0-b5c5-410c-b1f0-523873981e8d2026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
Pravastatin SodiumPRAVASTATIN SODIUMNorthwind Health Company, LLCdb0e9c21-dc25-629a-e053-2a95a90a5ac32026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutions45f0fd53-7160-4361-ba0b-3401095441c42025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutions635062df-9a84-4ff8-874c-dcee581a55552025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
Pravastatin SodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.095ac6fd-fdfb-4207-b15d-8e93bee378c32025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions4015f184-b57e-4d32-9cef-15c6e1cefe242025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutionsb7a84cc1-f6e4-40be-9e68-cf7d43bbd6172025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutionsbdf02140-3647-498e-ba0a-f4ca920b4e902025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions88e3b5b1-8379-492b-8902-af77f87ad9952025-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCoupler LLC2e0655ba-b1ba-789b-e063-6294a90a0a192025-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCoupler LLC2e07ad78-1059-e0ec-e063-6394a90a9bff2025-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
Pravastatin SodiumPRAVASTATIN SODIUMAmerican Health Packaging056475c8-59c2-469c-9175-7162065726f52025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
Pravastatin SodiumPRAVASTATIN SODIUMQuality Care Products, LLC465dc828-966e-4bb4-b935-ef26583dd4e62024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNCS HealthCare of KY, LLC dba Vangard Labs27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae2024-12-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCIPLA USA INC.678dfe58-3200-4c3d-9718-365aa47d070f2024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutionsa75de063-c751-4647-bb9e-d4050c1e31fc2023-12-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
Pravastatin SodiumPRAVASTATIN SODIUMNorthStar RxLLCce15ad07-3286-478f-9f30-1db6a45ed4022023-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d2023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987
Pravastatin SodiumPRAVASTATIN SODIUMGlenmark Pharmaceuticals Inc., USA6ca01de3-a0f9-4cfb-b36a-723c7c42e2a42022-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077987
application number: ANDA077987

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8158-390061581583930 TABLET in 1 BLISTER PACK (0615-8158-39) 30 tablet2018-07-100000-00-00NoNoCurrent