NDC 72485-223

Gemcitabine

Gemcitabine Hydrochloride

Gemcitabine is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Armas Pharmaceuticals Inc.. The primary component is Gemcitabine Hydrochloride.

Product ID72485-223_470dbc2b-c18a-403d-b815-3c6e296a7f41
NDC72485-223
Product TypeHuman Prescription Drug
Proprietary NameGemcitabine
Generic NameGemcitabine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-01-15
Marketing CategoryANDA / ANDA
Application NumberANDA210991
Labeler NameArmas Pharmaceuticals Inc.
Substance NameGEMCITABINE HYDROCHLORIDE
Active Ingredient Strength2 g/52.6mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 72485-223-20

1 VIAL, SINGLE-DOSE in 1 CARTON (72485-223-20) > 52.6 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2020-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72485-223-20 [72485022320]

Gemcitabine INJECTION
Marketing CategoryANDA
Application NumberANDA210991
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-01-15

Drug Details

Active Ingredients

IngredientStrength
GEMCITABINE HYDROCHLORIDE2 g/52.6mL

Pharmacological Class

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

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

NDCBrand NameGeneric Name
0143-9394GemcitabineGemcitabine
0143-9395GemcitabineGemcitabine
0409-0181GemcitabineGEMCITABINE
0409-0182GemcitabineGEMCITABINE
0409-0183GemcitabineGEMCITABINE
0409-0185GemcitabineGEMCITABINE
0409-0186GemcitabineGEMCITABINE
0409-0187GEMCITABINEGEMCITABINE
16714-909GEMCITABINEGEMCITABINE HYDROCHLORIDE
16714-930GEMCITABINEGEMCITABINE HYDROCHLORIDE
68001-359GEMCITABINEGEMCITABINE
68001-348GEMCITABINEGEMCITABINE
68001-342GEMCITABINEGEMCITABINE
68001-350GEMCITABINEGEMCITABINE
70860-205GemcitabineGemcitabine
70860-204GemcitabineGemcitabine
71288-113GEMCITABINEGEMCITABINE
71288-114GEMCITABINEGEMCITABINE
16729-391GEMCITABINEGEMCITABINE
16729-419GEMCITABINEGEMCITABINE
16729-423GEMCITABINEGEMCITABINE
16729-426GEMCITABINEGEMCITABINE
25021-239GemcitabineGemcitabine
25021-234gemcitabinegemcitabine
25021-235gemcitabinegemcitabine
45963-624GemcitabineGemcitabine
45963-623GemcitabineGemcitabine
45963-636GemcitabineGemcitabine
50742-498GEMCITABINEGEMCITABINE
50742-497GEMCITABINEGEMCITABINE
50742-496GEMCITABINEGEMCITABINE
55111-686gemcitabinegemcitabine
55111-687gemcitabinegemcitabine
55390-391gemcitabinegemcitabine
60505-6114GemcitabineGemcitabine
60505-6113GemcitabineGemcitabine
60505-6115GemcitabineGemcitabine
63323-102GEMCITABINEGEMCITABINE
63323-125GEMCITABINEGEMCITABINE
63323-126GEMCITABINEGEMCITABINE
67457-618GemcitabineGemcitabine
67457-617GemcitabineGemcitabine
67457-616GemcitabineGemcitabine
16729-092GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
0002-7501GemzarGemcitabine hydrochloride
0002-7502GemzarGemcitabine hydrochloride

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