GEMCITABINE
- Product NDC
- 63323-126
- 11-digit product format
- 633230126
- Labeler code
- 63323
- Product ID
- 63323-126_ce96743d-23fc-4de4-9df1-b650d64f4cbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GEMCITABINE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA090799
- Marketing category
- ANDA
- Marketing start
- 2011-07-26
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 2 g/50mL
- 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 | 2 g/50mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U347PV74IL |
| Rxcui | 1719000, 1719003, 1719005 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-126-03 | GEMCITABINE | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 19 |
| 63323-126-03 | GEMCITABINE | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 50 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GEMCITABINE HYDROCHLORIDE | ACTIVE INGREDIENT | U347PV74IL | GEMCITABINE HYDROCHLORIDE (GEMCITABINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] | 10 | |
| GEMCITABINE | ACTIVE MOIETY | B76N6SBZ8R | GEMCITABINE HYDROCHLORIDE (GEMCITABINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] | 10 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | GEMCITABINE HYDROCHLORIDE (GEMCITABINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] | 10 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | GEMCITABINE HYDROCHLORIDE (GEMCITABINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] | 10 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | GEMCITABINE HYDROCHLORIDE (GEMCITABINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] | 10 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | GEMCITABINE HYDROCHLORIDE (GEMCITABINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-126 | GEMCITABINE (GEMCITABINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 19 | Current NDC, Legacy NDC, 2 package rows | 20241022_c550dd16-a5e8-44be-87f2-210c15bbb513.zip |
| 63323-126 | GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 7 | Current NDC, Legacy NDC | 20210129_b9347b14-7ca2-43f5-9ee8-7ba709ae6b52.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 |
|---|
| 63323-126-00 | 63323012600 | 1 VIAL in 1 CARTON (63323-126-00) > 50 mL in 1 VIAL | 1 vial | 2011-05-17 | 0000-00-00 | No | No | Current |
| 63323-126-03 | 63323012603 | 1 VIAL, SINGLE-DOSE in 1 BOX (63323-126-03) / 50 mL in 1 VIAL, SINGLE-DOSE | | 2011-07-26 | 0000-00-00 | No | No | Current |