GEMCITABINE
- Product NDC
- 68001-359
- 11-digit product format
- 680010359
- Labeler code
- 68001
- Product ID
- 68001-359_049982fe-a321-b868-e063-6294a90ae861
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GEMCITABINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BluePoint Laboratories
- Application
- NDA209604
- Marketing category
- NDA
- Marketing start
- 2018-05-25
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 100 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 | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U347PV74IL |
| Rxcui | 1998783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68001-359-37 | GEMCITABINE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 68001-359-37 | GEMCITABINE | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-359 | GEMCITABINE INJECTION, SOLUTION [BLUEPOINT LABORATORIES] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230912_4031017d-d768-46de-8081-476bcb883f5e.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 |
|---|
| 68001-359-37 | 68001035937 | 1 VIAL, MULTI-DOSE in 1 CARTON (68001-359-37) / 20 mL in 1 VIAL, MULTI-DOSE | 2018-05-25 | 0000-00-00 | No | No | Current |