GEMCITABINE
- Product NDC
- 68001-350
- 11-digit product format
- 680010350
- Labeler code
- 68001
- Product ID
- 68001-350_830c5aa5-79d2-4342-9d53-070bfd7ab05c
- 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
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68001-350-68 | GEMCITABINE | 15 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 15 | | 5 |
| 68001-350-68 | GEMCITABINE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-350 | GEMCITABINE INJECTION, SOLUTION [BLUEPOINT LABORATORIES] | 5 | 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 |
|---|
| 68001-350-68 | 68001035068 | 1 VIAL, MULTI-DOSE in 1 CARTON (68001-350-68) > 15 mL in 1 VIAL, MULTI-DOSE | 2018-05-25 | 0000-00-00 | No | No | Current |