NDC 68083-148

gemcitabine hydrochloride

Gemcitabine Hydrochloride

gemcitabine hydrochloride is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Gemcitabine Hydrochloride.

• Product ID: 68083-148_5670120a-b079-4147-9450-91b0fa9e75cc
• NDC: 68083-148
• Product Type: Human Prescription Drug
• Proprietary Name: gemcitabine hydrochloride
• Generic Name: Gemcitabine Hydrochloride
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-02-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204520
• Labeler Name: Gland Pharma Limited
• Substance Name: GEMCITABINE HYDROCHLORIDE
• Active Ingredient Strength: 200 mg/5mL
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68083-148-01

1 VIAL in 1 CARTON (68083-148-01) > 5 mL in 1 VIAL

• Marketing Start Date: 2016-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68083-148-01 [68083014801]

gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204520
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-02-01

Drug Details

Active Ingredients

Ingredient	Strength
GEMCITABINE HYDROCHLORIDE	200 mg/5mL

OpenFDA Data

• SPL SET ID: 9f8fe5ba-943f-4f0a-9618-6083101faa28
• Manufacturer:
  • Gland Pharma Limited
• UNII:
  • U347PV74IL
• RxNorm Concept Unique ID - RxCUI:
  • 1719000
  • 1719003

Pharmacological Class

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

NDC Crossover Matching brand name "gemcitabine hydrochloride" or generic name "Gemcitabine Hydrochloride"

NDC	Brand Name	Generic Name
16729-092	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
16729-117	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
16729-118	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
23155-213	Gemcitabine hydrochloride	Gemcitabine hydrochloride
23155-214	Gemcitabine hydrochloride	Gemcitabine hydrochloride
23155-483	Gemcitabine hydrochloride	Gemcitabine hydrochloride
23155-484	Gemcitabine hydrochloride	Gemcitabine hydrochloride
23155-528	Gemcitabine hydrochloride	Gemcitabine hydrochloride
23155-529	Gemcitabine hydrochloride	Gemcitabine hydrochloride
45963-612	gemcitabine hydrochloride	gemcitabine hydrochloride
45963-619	gemcitabine hydrochloride	gemcitabine hydrochloride
45963-620	gemcitabine hydrochloride	gemcitabine hydrochloride
68001-282	Gemcitabine Hydrochloride	Gemcitabine Hydrochloride
68083-149	gemcitabine hydrochloride	gemcitabine hydrochloride
68083-148	gemcitabine hydrochloride	gemcitabine hydrochloride
69097-314	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
69097-313	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
67457-462	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
67457-463	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
67457-464	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
16714-909	GEMCITABINE	GEMCITABINE HYDROCHLORIDE
16714-930	GEMCITABINE	GEMCITABINE HYDROCHLORIDE
25021-234	gemcitabine	gemcitabine hydrochloride
25021-235	gemcitabine	gemcitabine hydrochloride
0002-7501	Gemzar	Gemcitabine hydrochloride
0002-7502	Gemzar	Gemcitabine hydrochloride