Pravastatin Sodium

Product NDC
51079-458
11-digit product format
510790458
Labeler code
51079
Product ID
51079-458_311a7c70-966e-2400-e063-6394a90aae6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA076056
Marketing category
ANDA
Marketing start
2006-05-22
Marketing end
2026-08-31
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
Rxcui904467, 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
51079-458-01Pravastatin Sodium1 in 1 BLISTER PACKTABLET114
51079-458-20Pravastatin Sodium100 in 1 CARTONTABLET10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-458-01EA - Each51079-458963edd6c-2f2a-4b06-a616-749ba40b866812012-07-24
51079-458-20EA - Each51079-458a9382d86-5311-4615-9d65-0246730e5d9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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 [CARDINAL HEALTH]3
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-458PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]14Current NDC, Legacy NDC, 2 package rows20250326_1b00f510-c86d-46f6-b427-311a8fd14955.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSNca779f66-4b9d-41da-ad0e-e4f58db9fbac15
904475pravastatin sodium 40 MG Oral TabletPSNca779f66-4b9d-41da-ad0e-e4f58db9fbac15
904467pravastatin sodium 20 MG Oral TabletSCDca779f66-4b9d-41da-ad0e-e4f58db9fbac15
904475pravastatin sodium 40 MG Oral TabletSCDca779f66-4b9d-41da-ad0e-e4f58db9fbac15
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-458-01510790458011 in 1 BLISTER PACKHistorical
51079-458-2051079045820100 BLISTER PACK in 1 CARTON (51079-458-20) / 1 TABLET in 1 BLISTER PACK (51079-458-01) 100 blister pack2006-05-222026-08-31NoNoCurrent