Pazopanib

Product NDC
42291-939
11-digit product format
422910939
Labeler code
42291
Product ID
42291-939_48c0ee87-f725-1a71-e063-6394a90a72d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pazopanib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA217517
Marketing category
ANDA
Marketing start
2024-04-23
Substance
PAZOPANIB HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pazopanib
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAZOPANIB HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33Y9ANM545
Rxcui867502

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a22552f9-c212-7ece-256c-f50df49d1fe2Product name220250204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-939-12Pazopanib120 in 1 BOTTLETABLET, FILM COATED1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-939-12EA - Each42291-939095af943-1d00-4a58-994a-4a1fcfe4bc1d12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-939PAZOPANIB TABLET, FILM COATED [AVKARE]1Current NDC, 1 package rows20240425_16c5df52-0031-034d-e063-6294a90a1717.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
867502PAZOPanib 200 MG Oral TabletPSN16c5df52-0031-034d-e063-6294a90a17172
867502pazopanib 200 MG Oral TabletSCD16c5df52-0031-034d-e063-6294a90a17172
867502pazopanib (as pazopanib hydrochloride) 200 MG Oral TabletSY16c5df52-0031-034d-e063-6294a90a17172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42291-939-1242291093912120 TABLET, FILM COATED in 1 BOTTLE (42291-939-12) 2024-04-23NoNoCurrent