FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
0480-7270
11-digit product format
004807270
Labeler code
0480
Product ID
0480-7270_95e8c960-5096-43a9-8807-89cdf404a214
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA077793
Marketing category
ANDA
Marketing start
2023-02-09
Substance
PRAVASTATIN SODIUM
Active strength
80 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904481

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
0480-7270-10Pravastatin Sodium1000 in 1 BOTTLETABLET10004
0480-7270-98Pravastatin Sodium90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-7270-10EA - Each0480-727042cde61b-ec80-4d70-b6b8-2bb1b30d6e5512023-04-07
0480-7270-98EA - Each0480-7270695a5a3c-0b1f-4be6-be5d-b122d38806e512023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-7270PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS, INC.]4Current NDC, 2 package rows20250226_f66cb1c1-5ff1-4b0b-89d0-8ecaee26b0b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904481pravastatin sodium 80 MG Oral TabletPSNf66cb1c1-5ff1-4b0b-89d0-8ecaee26b0b84
904481pravastatin sodium 80 MG Oral TabletSCDf66cb1c1-5ff1-4b0b-89d0-8ecaee26b0b84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-7270-10004807270101000 TABLET in 1 BOTTLE (0480-7270-10) 1000 tablet2023-03-20NoNoHistorical
0480-7270-980048072709890 TABLET in 1 BOTTLE (0480-7270-98) 90 tablet2023-02-09NoNoHistorical