GEMCITABINE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Gemcitabine Hydrochloride.
Product ID | 50742-498_5a2513c4-3269-412f-91f2-0ed1446de796 |
NDC | 50742-498 |
Product Type | Human Prescription Drug |
Proprietary Name | GEMCITABINE |
Generic Name | Gemcitabine |
Dosage Form | Injection, Solution |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2019-02-26 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA210383 |
Labeler Name | Ingenus Pharmaceuticals, LLC |
Substance Name | GEMCITABINE HYDROCHLORIDE |
Active Ingredient Strength | 38 mg/mL |
Pharm Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2019-02-26 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA210383 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-02-26 |
Ingredient | Strength |
---|---|
GEMCITABINE HYDROCHLORIDE | 38 mg/mL |
SPL SET ID: | a15f5d83-6ba1-4891-9e26-ce23ddaf68c7 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
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 |