Pravastatin Sodium

Product NDC
16714-559
Requested package NDC
16714-559-02
11-digit product format
167140559
Labeler code
16714
Product ID
16714-559_fa078b35-ee9d-4b9f-bb8d-e77949c09f88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA077987
Marketing category
ANDA
Marketing start
2022-08-12
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
2026-12-31
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
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Pravastatin Sodium
Listing expiration
2026-12-31

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 · 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
ce15ad07-3286-478f-9f30-1db6a45ed402Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
36361c23-a766-1581-d616-2080c781a50cProduct name520190314
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-559-01Pravastatin Sodium90 in 1 BOTTLETABLET903
16714-559-02Pravastatin Sodium500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-559-01EA - Each16714-559b3e9f1c3-0f00-49e0-b252-c68009508f0e12022-11-07
16714-559-02EA - Each16714-559c430a10b-9a45-45ba-be11-0459b34dbc3212022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-559PRAVASTATIN SODIUM TABLET [NORTHSTAR RXLLC]3Current NDC, Legacy NDC, 2 package rows20230306_ce15ad07-3286-478f-9f30-1db6a45ed402.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
ndc (package): 16714-559-02
ndc (product): 16714-559
ndc11 (package): 16714055902
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSNce15ad07-3286-478f-9f30-1db6a45ed4023
904467pravastatin sodium 20 MG Oral TabletPSNce15ad07-3286-478f-9f30-1db6a45ed4023
904475pravastatin sodium 40 MG Oral TabletPSNce15ad07-3286-478f-9f30-1db6a45ed4023
904481pravastatin sodium 80 MG Oral TabletPSNce15ad07-3286-478f-9f30-1db6a45ed4023
904458pravastatin sodium 10 MG Oral TabletSCDce15ad07-3286-478f-9f30-1db6a45ed4023
904467pravastatin sodium 20 MG Oral TabletSCDce15ad07-3286-478f-9f30-1db6a45ed4023
904475pravastatin sodium 40 MG Oral TabletSCDce15ad07-3286-478f-9f30-1db6a45ed4023
904481pravastatin sodium 80 MG Oral TabletSCDce15ad07-3286-478f-9f30-1db6a45ed4023
904467pravastatin sodium 20 MG Oral TabletPSN4015f184-b57e-4d32-9cef-15c6e1cefe241
904467pravastatin sodium 20 MG Oral TabletPSNb7a84cc1-f6e4-40be-9e68-cf7d43bbd6171
904467pravastatin sodium 20 MG Oral TabletSCD4015f184-b57e-4d32-9cef-15c6e1cefe241
904467pravastatin sodium 20 MG Oral TabletSCDb7a84cc1-f6e4-40be-9e68-cf7d43bbd6171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-559-0216714055902500 TABLET in 1 BOTTLE (16714-559-02) 500 tablet2022-08-120000-00-00NoNoCurrent