GEMCITABINE
- Product NDC
- 71288-114
- 11-digit product format
- 712880114
- Labeler code
- 71288
- Product ID
- 71288-114_b696b925-51e8-48a8-881e-ae0a0373b3c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GEMCITABINE HYDROCHLORIDE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA091365
- Marketing category
- ANDA
- Marketing start
- 2018-11-01
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 1 g/1
- 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 | 1 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U347PV74IL |
| Rxcui | 1719000, 1719003 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-114-50 | GEMCITABINE | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
| 71288-114-50 | GEMCITABINE | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-114 | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250205_a5949d02-29eb-4626-ad35-b7614bb0fa95.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71288-114-50 | 71288011450 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-114-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2018-11-01 | 0000-00-00 | No | No | Current |