sunitinib malate

Generic: sunitinib malate

Labeler: dr.reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sunitinib malate
Generic Name sunitinib malate
Labeler dr.reddys laboratories inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sunitinib malate 12.5 mg/1

Manufacturer
Dr.Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-045
Product ID 43598-045_664e6a61-82ff-5756-1fc1-9266090d901e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215843
Listing Expiration 2026-12-31
Marketing Start 2022-11-30

Pharmacologic Class

Classes
kinase inhibitor [epc] protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598045
Hyphenated Format 43598-045

Supplemental Identifiers

RxCUI
616279 616285 616289 1541890
UPC
0343598048635 0343598046631 0343598045634 0343598047638
UNII
LVX8N1UT73

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sunitinib malate (source: ndc)
Generic Name sunitinib malate (source: ndc)
Application Number ANDA215843 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (43598-045-28) / 7 CAPSULE in 1 BLISTER PACK (43598-045-70)
  • 28 CAPSULE in 1 BOTTLE (43598-045-63)
source: ndc

Packages (2)

43598-045-28 4 BLISTER PACK in 1 CARTON (43598-045-28) / 7 CAPSULE in 1 BLISTER PACK (43598-045-70) 43598-045-63 28 CAPSULE in 1 BOTTLE (43598-045-63)

Ingredients (1)

sunitinib malate (12.5 mg/1)

Linked Drug Pages (1)

SUNITINIB MALATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "664e6a61-82ff-5756-1fc1-9266090d901e", "openfda": {"upc": ["0343598048635", "0343598046631", "0343598045634", "0343598047638"], "unii": ["LVX8N1UT73"], "rxcui": ["616279", "616285", "616289", "1541890"], "spl_set_id": ["96ce8850-b5ae-382b-8433-04949533af44"], "manufacturer_name": ["Dr.Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (43598-045-28)  / 7 CAPSULE in 1 BLISTER PACK (43598-045-70)", "package_ndc": "43598-045-28", "marketing_start_date": "20221130"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (43598-045-63)", "package_ndc": "43598-045-63", "marketing_start_date": "20221130"}], "brand_name": "SUNITINIB MALATE", "product_id": "43598-045_664e6a61-82ff-5756-1fc1-9266090d901e", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "43598-045", "generic_name": "SUNITINIB MALATE", "labeler_name": "Dr.Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SUNITINIB MALATE", "active_ingredients": [{"name": "SUNITINIB MALATE", "strength": "12.5 mg/1"}], "application_number": "ANDA215843", "marketing_category": "ANDA", "marketing_start_date": "20221130", "listing_expiration_date": "20261231"}