gemcitabine
- Product NDC
- 55390-391
- 11-digit product format
- 553900391
- Labeler code
- 55390
- Product ID
- 55390-391_4cef5f77-82b5-ba03-1f26-4fdeb8af63fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gemcitabine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Bedford Laboratories
- Application
- ANDA091365
- Marketing category
- ANDA
- Marketing start
- 2012-03-19
- Marketing end
- 0000-00-00
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 40 mg/mL
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55390-391-10 | gemcitabine | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 5 |
| 55390-391-10 | gemcitabine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
| 55390-391-50 | gemcitabine | 25 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 25 | | 5 |
| 55390-391-50 | gemcitabine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| gemcitabine hydrochloride | ACTIVE INGREDIENT | U347PV74IL | GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES] | 5 | |
| gemcitabine | ACTIVE MOIETY | B76N6SBZ8R | GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES] | 5 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES] | 5 | |
| sodium acetate | INACTIVE INGREDIENT | 4550K0SC9B | GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55390-391 | GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES] | 5 | Legacy NDC, 4 package rows | 20140616_aa445f68-1e55-a587-76dc-def068bc9c74.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 55390-391-10 | 55390039110 | 5 mL in 1 VIAL, SINGLE-USE | 5 ml | Historical |
| 55390-391-50 | 55390039150 | 25 mL in 1 VIAL, SINGLE-USE | 25 ml | Historical |