PRAVASTATIN SODIUM

Product NDC
67046-1621
11-digit product format
670461621
Labeler code
67046
Product ID
67046-1621_4573c662-e92e-dffe-e063-6294a90a71da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA076341
Marketing category
ANDA
Marketing start
2025-12-08
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
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
A076341-001PRAVASTATIN SODIUMPRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23
A076341-002PRAVASTATIN SODIUMPRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23
A076341-003PRAVASTATIN SODIUMPRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23
A076341-004PRAVASTATIN 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
A076341-001AB
A076341-002AB
A076341-003AB
A076341-004AB

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 UTC2026-02A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076341-004PRAVASTATIN 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 UTC2026-02A076341-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076341-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076341-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076341-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076341-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076341-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076341-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076341-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076341-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076341-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076341-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076341-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076341-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076341-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076341-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076341-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
PRAVASTATIN SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM10 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4573c42b-6d4a-e001-e063-6294a90acea1Available 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
67046-1621-3PRAVASTATIN SODIUM30 in 1 BLISTER PACKTABLET301

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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.e4dbaa72-7b3e-4aef-983b-90efb2b343cd2026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.c5f611aa-9974-422e-a353-5d834a33937c2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.8dbdc80d-9d8c-4e22-9108-d87a77e07a6b2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.5ecd9fd1-7662-412d-99c5-13c77188748c2026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.76e5fdf8-bd03-4cd5-9361-e61678cb3de92026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCardinal Health 107, LLC3e218ad6-5b47-4cca-81be-ebaea57959642026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCardinal Health 107, LLC9289f9ed-b6e3-4e81-bdb8-6aedbd5288a92026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack14390bfa-3bcb-43e1-936c-1977cb37427d2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack8d1bf7a5-bf11-47e3-afca-dcc13f2d30682026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNorthwind Health Company, LLC4fad5d73-aa79-58f2-e063-6294a90af4aa2026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutions93b0e546-9e0f-40d1-9b1e-082bf16400a42026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutionsd69e8af8-dbd4-43d9-8e9a-4aed3923a17c2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackf4b330ce-dfb0-4e4e-9f37-482458820c662026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMMajor Pharmaceuticals1d5bce9c-a788-4c52-a69e-c53174b8d0612026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNCS HealthCare of KY, LLC dba Vangard Labs64ccb4b5-b77e-4b23-8c74-4685287edb4b2026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMApotex Corp.dcf45e4f-b46e-6fbb-b67a-2ff619ab17802026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackc0b1b483-1a19-4966-89b1-118ec660f2032026-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAvPAKba4ac602-46fa-8386-e053-2995a90a97642026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutions3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf212026-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNorthwind Health Company, LLCdb5b8821-dca8-9322-e053-2a95a90abdc32026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN4573c42b-6d4a-e001-e063-6294a90acea11
904458pravastatin sodium 10 MG Oral TabletSCD4573c42b-6d4a-e001-e063-6294a90acea11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1621-36704616210330 TABLET in 1 BLISTER PACK (67046-1621-3) 30 tablet2025-12-08NoNoCurrent