Gemcitabine
- Product NDC
- 0143-9341
- 11-digit product format
- 001439341
- Labeler code
- 0143
- Product ID
- 0143-9341_e9bd951d-0a47-409c-aa7c-2df9157d94e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemcitabine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA213175
- Marketing category
- ANDA
- Marketing start
- 2025-10-17
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 38 mg/mL
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| U347PV74IL | GEMCITABINE HYDROCHLORIDE | 122111-03-9 | GEMCITABINE HYDROCHLORIDE |
| B76N6SBZ8R | GEMCITABINE | 95058-81-4 | Gemcitabine |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0143-9341-01 | 00143934101 | 1 VIAL in 1 CARTON (0143-9341-01) / 26.3 mL in 1 VIAL | 1 vial | 2025-10-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gemcitabine | Hikma Pharmaceuticals USA Inc. | 2025-10-24 | HUMAN PRESCRIPTION DRUG LABEL | 4 |