Gemcitabine
- Product NDC
- 0409-0186
- 11-digit product format
- 004090186
- Labeler code
- 0409
- Product ID
- 0409-0186_111b13bb-6793-4b33-b845-0dc9b46837de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GEMCITABINE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA078339
- Marketing category
- ANDA
- Marketing start
- 2011-07-26
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 38 mg/mL
- 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 | 38 mg/mL |
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 |
|---|
| 0409-0186-01 | Gemcitabine | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 25 | | 27 |
| 0409-0186-01 | Gemcitabine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 27 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-0186 | GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 27 | Current NDC, Legacy NDC, 2 package rows | 20240903_d16907e7-a8c8-4039-ace4-cf4e24ba68c0.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 |
|---|
| 0409-0186-01 | 00409018601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0186-01) / 25 mL in 1 VIAL, SINGLE-DOSE | 2011-07-26 | 0000-00-00 | No | No | Current |