NDC 67457-462

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 Mylan Institutional Llc. The primary component is Gemcitabine Hydrochloride.

• Product ID: 67457-462_449bf070-70aa-48bd-981e-448695aaac9d
• NDC: 67457-462
• 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: 2014-09-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200145
• Labeler Name: Mylan Institutional LLC
• Substance Name: GEMCITABINE HYDROCHLORIDE
• Active Ingredient Strength: 1 g/25mL
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 67457-462-01

1 VIAL in 1 CARTON (67457-462-01) > 25 mL in 1 VIAL

• Marketing Start Date: 2014-09-22
• Marketing End Date: 2021-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-462-01 [67457046201]

GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA200145
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-22
• Marketing End Date: 2021-04-30

Drug Details

Active Ingredients

Ingredient	Strength
GEMCITABINE HYDROCHLORIDE	1 g/25mL

OpenFDA Data

• SPL SET ID: fdf52dca-732c-4a1a-9475-e9e1e3af4ce8
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • U347PV74IL
• RxNorm Concept Unique ID - RxCUI:
  • 1719005
  • 1719000
  • 1719003
• UPC Code:
  • 0367457464206
  • 0367457463025
  • 0367457462011

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