gemcitabine
- Product NDC
- 25021-234
- 11-digit product format
- 250210234
- Labeler code
- 25021
- Product ID
- 25021-234_595a8cf5-412a-482d-8d77-979741ee4912
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gemcitabine hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA202485
- Marketing category
- ANDA
- Marketing start
- 2014-12-29
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 200 mg/5mL
- 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 | 200 mg/5mL |
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 |
|---|
| 25021-234-10 | gemcitabine | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 12 |
| 25021-234-10 | gemcitabine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| gemcitabine hydrochloride | ACTIVE INGREDIENT | U347PV74IL | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 2 | |
| gemcitabine | ACTIVE MOIETY | B76N6SBZ8R | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 2 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 2 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 2 | |
| sodium acetate | INACTIVE INGREDIENT | 4550K0SC9B | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 2 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-234 | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240918_44bcc16c-341d-49e8-a1c6-95d084667aca.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 |
|---|
| 25021-234-10 | 25021023410 | 1 VIAL in 1 CARTON (25021-234-10) / 5 mL in 1 VIAL | 1 vial | 2014-12-29 | 0000-00-00 | No | No | Current |