pazopanib

Product NDC
82293-022
11-digit product format
822930022
Labeler code
82293
Product ID
82293-022_2007980f-ffca-6d8f-e063-6294a90ae3ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pazopanib hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novugen Pharma (USA) LLC.
Application
ANDA218231
Marketing category
ANDA
Marketing start
2024-04-24
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
82293-022-10pazopanib120 in 1 BOTTLETABLET, FILM COATED1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82293-022-10EA - Each82293-022a7bf4806-1e02-4c64-98a2-8cadad3e455812024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82293-022PAZOPANIB (PAZOPANIB HYDROCHLORIDE) TABLET, FILM COATED [NOVUGEN PHARMA (USA) LLC.]2Current NDC, 1 package rows20240820_25305d33-caa0-4577-8b7b-06e430c34c39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
867502PAZOPanib 200 MG Oral TabletPSN25305d33-caa0-4577-8b7b-06e430c34c392
867502pazopanib 200 MG Oral TabletSCD25305d33-caa0-4577-8b7b-06e430c34c392
867502pazopanib (as pazopanib hydrochloride) 200 MG Oral TabletSY25305d33-caa0-4577-8b7b-06e430c34c392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82293-022-1082293002210120 TABLET, FILM COATED in 1 BOTTLE (82293-022-10) 2024-04-24NoNoHistorical