pravastatin sodium

Product NDC
68382-070
Requested package NDC
68382-070-05
11-digit product format
683820070
Labeler code
68382
Product ID
68382-070_12014495-c66a-407e-aa7b-5c58596230ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA077751
Marketing category
ANDA
Marketing start
2010-03-30
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68382-07068382-070-05DDiscontinued by firm2026-10-05

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 · 2 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 packagepackage68382-07068382-070-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-07068382-070-05DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077751-001PRAVASTATIN SODIUMPRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30
A077751-002PRAVASTATIN SODIUMPRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30
A077751-003PRAVASTATIN SODIUMPRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30
A077751-004PRAVASTATIN SODIUMPRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077751-002AB
A077751-003AB
A077751-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-3084e616aacf4f…
2026-08-18 06:07:402026-07A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-305bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 133 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077751-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077751-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077751-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A077751-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077751-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077751-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077751-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077751-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077751-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077751-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077751-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077751-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077751-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077751-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077751-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077751-002AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-070-05EA - Each68382-070bb4f90fc-b5a3-4aad-a92d-c59f0b29099e12012-07-24
68382-070-16EA - Each68382-0700b2ee457-6080-4f64-a3db-bfe681f6f90f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6OPRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]1000
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6OPRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPRAVASTATIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6OPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN6024cde1-4a34-4004-8ab9-b0eb5c5625cd1
904458pravastatin sodium 10 MG Oral TabletPSNa8896399-04cd-42d7-894f-88ffc92f15571
904458pravastatin sodium 10 MG Oral TabletSCD6024cde1-4a34-4004-8ab9-b0eb5c5625cd1
904458pravastatin sodium 10 MG Oral TabletSCDa8896399-04cd-42d7-894f-88ffc92f15571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-070-0568382007005500 TABLET in 1 BOTTLE (68382-070-05) 500 tablet2010-03-300000-00-00NoNoCurrent