NDC 71288-113

GEMCITABINE

Gemcitabine Hydrochloride

GEMCITABINE is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is Gemcitabine Hydrochloride.

• Product ID: 71288-113_ac076bca-972b-4521-92cc-d49050babc80
• NDC: 71288-113
• Product Type: Human Prescription Drug
• Proprietary Name: GEMCITABINE
• Generic Name: Gemcitabine Hydrochloride
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-11-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091365
• Labeler Name: Meitheal Pharmaceuticals Inc.
• Substance Name: GEMCITABINE HYDROCHLORIDE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 71288-113-10

1 VIAL, SINGLE-DOSE in 1 CARTON (71288-113-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2018-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71288-113-10 [71288011310]

GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA091365
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-01

Drug Details

Active Ingredients

Ingredient	Strength
GEMCITABINE HYDROCHLORIDE	200 mg/1

OpenFDA Data

• SPL SET ID: a5949d02-29eb-4626-ad35-b7614bb0fa95
• Manufacturer:
  • Meitheal Pharmaceuticals Inc.
• 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" or generic name "Gemcitabine Hydrochloride"

NDC	Brand Name	Generic Name
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
16714-909	GEMCITABINE	GEMCITABINE HYDROCHLORIDE
16714-930	GEMCITABINE	GEMCITABINE HYDROCHLORIDE
68001-359	GEMCITABINE	GEMCITABINE
68001-348	GEMCITABINE	GEMCITABINE
68001-342	GEMCITABINE	GEMCITABINE
68001-350	GEMCITABINE	GEMCITABINE
70860-205	Gemcitabine	Gemcitabine
70860-204	Gemcitabine	Gemcitabine
71288-113	GEMCITABINE	GEMCITABINE
71288-114	GEMCITABINE	GEMCITABINE
16729-391	GEMCITABINE	GEMCITABINE
16729-419	GEMCITABINE	GEMCITABINE
16729-423	GEMCITABINE	GEMCITABINE
16729-426	GEMCITABINE	GEMCITABINE
25021-239	Gemcitabine	Gemcitabine
25021-234	gemcitabine	gemcitabine
25021-235	gemcitabine	gemcitabine
45963-624	Gemcitabine	Gemcitabine
45963-623	Gemcitabine	Gemcitabine
45963-636	Gemcitabine	Gemcitabine
50742-498	GEMCITABINE	GEMCITABINE
50742-497	GEMCITABINE	GEMCITABINE
50742-496	GEMCITABINE	GEMCITABINE
55111-686	gemcitabine	gemcitabine
55111-687	gemcitabine	gemcitabine
55390-391	gemcitabine	gemcitabine
60505-6114	Gemcitabine	Gemcitabine
60505-6113	Gemcitabine	Gemcitabine
60505-6115	Gemcitabine	Gemcitabine
63323-102	GEMCITABINE	GEMCITABINE
63323-125	GEMCITABINE	GEMCITABINE
63323-126	GEMCITABINE	GEMCITABINE
67457-618	Gemcitabine	Gemcitabine
67457-617	Gemcitabine	Gemcitabine
67457-616	Gemcitabine	Gemcitabine
16729-092	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
0002-7501	Gemzar	Gemcitabine hydrochloride
0002-7502	Gemzar	Gemcitabine hydrochloride