FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
0093-7201
11-digit product format
000937201
Labeler code
0093
Product ID
0093-7201_72579e23-23ef-4ab7-ad64-24d5ea7997eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076056
Marketing category
ANDA
Marketing start
2006-04-25
Marketing end
2026-12-31
Substance
PRAVASTATIN SODIUM
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pravastatin Sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904458, 904467, 904475

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
0093-7201-10Pravastatin Sodium1000 in 1 BOTTLETABLET100027
0093-7201-98Pravastatin Sodium90 in 1 BOTTLETABLET9027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7201-10EA - Each0093-72015bd9809e-8021-459f-b9f8-51588b6c0ee412012-07-24
0093-7201-98EA - Each0093-72018d701293-1d0a-4a8c-9108-14e35e8cde4812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]12
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]12
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]12
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]12
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]12
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]12
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]4
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]4
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIPRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]4
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [MEDVANTX, INC.]1
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [MEDVANTX, INC.]1
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAVASTATIN SODIUM TABLET [MEDVANTX, INC.]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPRAVASTATIN SODIUM TABLET [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [MEDVANTX, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [MEDVANTX, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [MEDVANTX, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPRAVASTATIN SODIUM TABLET [MEDVANTX, INC.]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIPRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIPRAVASTATIN SODIUM TABLET [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7201PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA, INC.]27Current NDC, Legacy NDC, 2 package rows20250507_99e0e848-f8f3-4b42-b880-8fbc42633948.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN99e0e848-f8f3-4b42-b880-8fbc4263394827
904467pravastatin sodium 20 MG Oral TabletPSN99e0e848-f8f3-4b42-b880-8fbc4263394827
904475pravastatin sodium 40 MG Oral TabletPSN99e0e848-f8f3-4b42-b880-8fbc4263394827
904458pravastatin sodium 10 MG Oral TabletSCD99e0e848-f8f3-4b42-b880-8fbc4263394827
904467pravastatin sodium 20 MG Oral TabletSCD99e0e848-f8f3-4b42-b880-8fbc4263394827
904475pravastatin sodium 40 MG Oral TabletSCD99e0e848-f8f3-4b42-b880-8fbc4263394827
904467pravastatin sodium 20 MG Oral TabletPSN1b00f510-c86d-46f6-b427-311a8fd1495514
904475pravastatin sodium 40 MG Oral TabletPSN1b00f510-c86d-46f6-b427-311a8fd1495514
904467pravastatin sodium 20 MG Oral TabletSCD1b00f510-c86d-46f6-b427-311a8fd1495514
904475pravastatin sodium 40 MG Oral TabletSCD1b00f510-c86d-46f6-b427-311a8fd1495514
904467pravastatin sodium 20 MG Oral TabletPSN0c4b59f1-92a8-44f8-8b4c-691f3577746010
904467pravastatin sodium 20 MG Oral TabletSCD0c4b59f1-92a8-44f8-8b4c-691f3577746010
904467pravastatin sodium 20 MG Oral TabletPSNf6ddb6c0-d0b4-2297-e053-6294a90a83c93
904467pravastatin sodium 20 MG Oral TabletSCDf6ddb6c0-d0b4-2297-e053-6294a90a83c93
904458pravastatin sodium 10 MG Oral TabletPSNc129f662-9ae7-45b6-9a02-15b569e051fc1
904458pravastatin sodium 10 MG Oral TabletPSNa5ca8004-9a18-4030-a56c-8938c4823c641
904467pravastatin sodium 20 MG Oral TabletPSN7abc1825-182d-40bc-9f7f-968e197b42461
904467pravastatin sodium 20 MG Oral TabletPSNdad83d68-f35a-42ca-a65c-f95677e1c9ca1
904467pravastatin sodium 20 MG Oral TabletPSNc129f662-9ae7-45b6-9a02-15b569e051fc1
904467pravastatin sodium 20 MG Oral TabletPSNa5ca8004-9a18-4030-a56c-8938c4823c641
904467pravastatin sodium 20 MG Oral TabletPSN55f8cf43-bf8b-4729-9e5a-32fcc9696e021
904467pravastatin sodium 20 MG Oral TabletPSN2d40e473-f79a-e50e-e063-6294a90a4d9e1
904467pravastatin sodium 20 MG Oral TabletPSN4f9ada33-5592-4780-926d-1af49a8e064e1
904475pravastatin sodium 40 MG Oral TabletPSNa5ca8004-9a18-4030-a56c-8938c4823c641
904475pravastatin sodium 40 MG Oral TabletPSNc129f662-9ae7-45b6-9a02-15b569e051fc1
904481pravastatin sodium 80 MG Oral TabletPSNa5ca8004-9a18-4030-a56c-8938c4823c641
904458pravastatin sodium 10 MG Oral TabletSCDa5ca8004-9a18-4030-a56c-8938c4823c641
904458pravastatin sodium 10 MG Oral TabletSCDc129f662-9ae7-45b6-9a02-15b569e051fc1
904467pravastatin sodium 20 MG Oral TabletSCD4f9ada33-5592-4780-926d-1af49a8e064e1
904467pravastatin sodium 20 MG Oral TabletSCD7abc1825-182d-40bc-9f7f-968e197b42461
904467pravastatin sodium 20 MG Oral TabletSCD55f8cf43-bf8b-4729-9e5a-32fcc9696e021
904467pravastatin sodium 20 MG Oral TabletSCDdad83d68-f35a-42ca-a65c-f95677e1c9ca1
904467pravastatin sodium 20 MG Oral TabletSCDc129f662-9ae7-45b6-9a02-15b569e051fc1
904467pravastatin sodium 20 MG Oral TabletSCD2d40e473-f79a-e50e-e063-6294a90a4d9e1
904467pravastatin sodium 20 MG Oral TabletSCDa5ca8004-9a18-4030-a56c-8938c4823c641
904475pravastatin sodium 40 MG Oral TabletSCDc129f662-9ae7-45b6-9a02-15b569e051fc1
904475pravastatin sodium 40 MG Oral TabletSCDa5ca8004-9a18-4030-a56c-8938c4823c641
904481pravastatin sodium 80 MG Oral TabletSCDa5ca8004-9a18-4030-a56c-8938c4823c641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-7201-10000937201101000 TABLET in 1 BOTTLE (0093-7201-10) 1000 tablet2006-04-252026-12-31NoNoCurrent
0093-7201-980009372019890 TABLET in 1 BOTTLE (0093-7201-98) 90 tablet2006-04-252026-08-31NoNoCurrent