NDC 62756-008

INFUGEM

Gemcitabine

INFUGEM is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Gemcitabine Hydrochloride.

• Product ID: 62756-008_6fc95d4c-11c7-4877-b9fe-be5521bae272
• NDC: 62756-008
• Product Type: Human Prescription Drug
• Proprietary Name: INFUGEM
• Generic Name: Gemcitabine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-10-01
• Marketing Category: NDA / NDA
• Application Number: NDA208313
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: GEMCITABINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 62756-008-60

1 POUCH in 1 CARTON (62756-008-60) > 1 BAG in 1 POUCH > 130 mL in 1 BAG

• Marketing Start Date: 2018-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62756-008-60 [62756000860]

INFUGEM INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208313
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-10-01

Drug Details

Active Ingredients

Ingredient	Strength
GEMCITABINE HYDROCHLORIDE	10 mg/mL

OpenFDA Data

• SPL SET ID: 4e7e5088-d476-40e2-8cbd-dfeed4ddd166
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • U347PV74IL
• RxNorm Concept Unique ID - RxCUI:
  • 2058893
  • 2058890
  • 2058858
  • 2058927
  • 2058928
  • 2058933
  • 2058866
  • 2058867
  • 2058934
  • 2058912
  • 2058863
  • 2058918
  • 2058892
  • 2058880
  • 2058881
  • 2058882
  • 2058883
  • 2058891
  • 2058895
  • 2058894

Pharmacological Class

• Nucleic Acid Synthesis Inhibitors [MoA]
• Nucleoside Metabolic Inhibitor [EPC]

NDC Crossover Matching brand name "INFUGEM" or generic name "Gemcitabine"

NDC	Brand Name	Generic Name
62756-614	INFUGEM	INFUGEM
62756-073	INFUGEM	INFUGEM
62756-219	INFUGEM	INFUGEM
62756-746	INFUGEM	INFUGEM
62756-974	INFUGEM	INFUGEM
62756-438	INFUGEM	INFUGEM
62756-533	INFUGEM	INFUGEM
62756-321	INFUGEM	INFUGEM
62756-008	INFUGEM	INFUGEM
62756-102	INFUGEM	INFUGEM
0143-9394	Gemcitabine	Gemcitabine
0143-9395	Gemcitabine	Gemcitabine
0409-0181	Gemcitabine	GEMCITABINE
0409-0182	Gemcitabine	GEMCITABINE
0409-0183	Gemcitabine	GEMCITABINE
0409-0185	Gemcitabine	GEMCITABINE
0409-0186	Gemcitabine	GEMCITABINE
0409-0187	GEMCITABINE	GEMCITABINE
16729-391	GEMCITABINE	GEMCITABINE
16729-419	GEMCITABINE	GEMCITABINE
16729-423	GEMCITABINE	GEMCITABINE
16729-426	GEMCITABINE	GEMCITABINE