Gemcitabine is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Athenex Pharmaceutical Division, Llc.. The primary component is Gemcitabine Hydrochloride.
| Product ID | 70860-205_6f2f489a-c059-4d82-9557-d1b4cb5b5753 |
| NDC | 70860-205 |
| 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 | 2017-07-31 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA204520 |
| Labeler Name | Athenex Pharmaceutical Division, 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 |
| Marketing Start Date | 2017-07-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA204520 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-07-31 |
| Ingredient | Strength |
|---|---|
| GEMCITABINE HYDROCHLORIDE | 1 g/25mL |
| SPL SET ID: | a1170be9-f12d-475e-bad6-544005f12303 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| 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 |