Gemcitabine
- Product NDC
- 25021-239
- 11-digit product format
- 250210239
- Labeler code
- 25021
- Product ID
- 25021-239_adf9b715-8cef-4a0d-ba30-d948b2b04272
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gemcitabine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA209077
- Marketing category
- ANDA
- Marketing start
- 2019-01-15
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gemcitabine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GEMCITABINE HYDROCHLORIDE | 38 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U347PV74IL |
| Rxcui | 1720960, 1720975, 1720977 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25021-239-05 | Gemcitabine | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 8 |
| 25021-239-05 | Gemcitabine | 5.26 mL in 1 VIAL | INJECTION, SOLUTION | 5.26 | | 8 |
| 25021-239-26 | Gemcitabine | 26.3 mL in 1 VIAL | INJECTION, SOLUTION | 26.3 | | 8 |
| 25021-239-26 | Gemcitabine | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 8 |
| 25021-239-52 | Gemcitabine | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 8 |
| 25021-239-52 | Gemcitabine | 52.6 mL in 1 VIAL | INJECTION, SOLUTION | 52.6 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-239 | GEMCITABINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 8 | Current NDC, Legacy NDC, 6 package rows | 20250426_22af3507-4b4f-4cad-9d61-89ffc4aabbc7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 25021-239-05 | 25021023905 | 1 VIAL in 1 CARTON (25021-239-05) / 5.26 mL in 1 VIAL | 1 vial | 2019-01-15 | 0000-00-00 | No | No | Current |
| 25021-239-26 | 25021023926 | 1 VIAL in 1 CARTON (25021-239-26) / 26.3 mL in 1 VIAL | 1 vial | 2019-01-15 | 0000-00-00 | No | No | Current |
| 25021-239-52 | 25021023952 | 1 VIAL in 1 CARTON (25021-239-52) / 52.6 mL in 1 VIAL | 1 vial | 2019-01-15 | 0000-00-00 | No | No | Current |