NDC 63323-125

GEMCITABINE

Gemcitabine

GEMCITABINE is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Gemcitabine Hydrochloride.

• Product ID: 63323-125_239ba766-de5b-4268-8583-2d7e033849f2
• NDC: 63323-125
• Product Type: Human Prescription Drug
• Proprietary Name: GEMCITABINE
• Generic Name: Gemcitabine
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-07-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090799
• Labeler Name: Fresenius Kabi USA, 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: 2021-12-31

Packaging

NDC 63323-125-53

1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-53) > 25 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2011-07-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-125-94 [63323012594]

GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090799
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-07-26

NDC 63323-125-53 [63323012553]

GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090799
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-07-26

NDC 63323-125-50 [63323012550]

GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA077983
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-09-12
• Marketing End Date: 2014-01-31

Drug Details

Active Ingredients

Ingredient	Strength
GEMCITABINE HYDROCHLORIDE	1 g/26.3mL

OpenFDA Data

• SPL SET ID: d1f3951c-d13f-4662-ad4b-ecfc07f59104
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • U347PV74IL
• RxNorm Concept Unique ID - RxCUI:
  • 1719000
  • 1719003
• UPC Code:
  • 0363323125943
  • 0363323102944

Pharmacological Class

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

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

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
16729-391	GEMCITABINE	GEMCITABINE
16729-419	GEMCITABINE	GEMCITABINE
16729-423	GEMCITABINE	GEMCITABINE
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
16729-426	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