FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
68180-485
11-digit product format
681800485
Labeler code
68180
Product ID
68180-485_a173dd76-57cb-4066-a51f-26adfb79e861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA077917
Marketing category
ANDA
Marketing start
2008-07-24
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

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 Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904458, 904467, 904475, 904481

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
36361c23-a766-1581-d616-2080c781a50cProduct name520190314
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-485-02PRAVASTATIN SODIUM500 in 1 BOTTLETABLET50012
68180-485-03PRAVASTATIN SODIUM1000 in 1 BOTTLETABLET100012
68180-485-09PRAVASTATIN SODIUM90 in 1 BOTTLETABLET9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-485-02EA - Each68180-4854dae3057-f325-4f1d-9cec-7f925dfe0fbf12012-07-24
68180-485-09EA - Each68180-485bb5909e5-ad9f-4d2c-a787-90d94e5e20ee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]5
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BPRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOPRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UPRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-485PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 3 package rows20231221_1123d56c-16f0-4f81-b56f-67b1f343ae1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904467pravastatin sodium 20 MG Oral TabletPSN1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904475pravastatin sodium 40 MG Oral TabletPSN1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904481pravastatin sodium 80 MG Oral TabletPSN1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904458pravastatin sodium 10 MG Oral TabletSCD1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904467pravastatin sodium 20 MG Oral TabletSCD1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904475pravastatin sodium 40 MG Oral TabletSCD1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904481pravastatin sodium 80 MG Oral TabletSCD1123d56c-16f0-4f81-b56f-67b1f343ae1e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-485-0268180048502500 TABLET in 1 BOTTLE (68180-485-02) 500 tablet2008-07-240000-00-00NoNoCurrent
68180-485-03681800485031000 TABLET in 1 BOTTLE (68180-485-03) 1000 tablet2008-07-240000-00-00NoNoCurrent
68180-485-096818004850990 TABLET in 1 BOTTLE (68180-485-09) 90 tablet2008-07-240000-00-00NoNoCurrent