GEMCITABINE
- Product NDC
- 63323-125
- 11-digit product format
- 633230125
- Labeler code
- 63323
- Product ID
- 63323-125_4c447f74-d06c-459b-ba63-6b72aaf4fd2e
- 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
- 1 g/25mL
- 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/25mL |
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 |
|---|
| 63323-125-53 | GEMCITABINE | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 19 |
| 63323-125-53 | GEMCITABINE | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 25 | | 19 |
| 63323-125-94 | GEMCITABINE | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 25 | | 4 |
| 63323-125-94 | GEMCITABINE | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
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 |
|---|
| 63323-125 | 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 |
| 63323-125 | GEMCITABINE (GEMCITABINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 4 | Current NDC, Legacy NDC, 2 package rows | 20210302_d1f3951c-d13f-4662-ad4b-ecfc07f59104.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 |
|---|
| 63323-125-53 | 63323012553 | 1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-53) / 25 mL in 1 VIAL, SINGLE-DOSE | 2011-07-26 | 0000-00-00 | No | No | Current |
| 63323-125-94 | 63323012594 | 1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-94) / 25 mL in 1 VIAL, SINGLE-DOSE | 2011-07-26 | 0000-00-00 | No | No | Current |