gemcitabine hydrochloride
- Product NDC
- 68083-148
- 11-digit product format
- 680830148
- Labeler code
- 68083
- Product ID
- 68083-148_35c72954-279a-45fe-aa22-2b97e20b7b0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gemcitabine hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA204520
- Marketing category
- ANDA
- Marketing start
- 2016-02-01
- 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 hydrochloride
- 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 |
|---|
| 68083-148-01 | gemcitabine hydrochloride | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 14 |
| 68083-148-01 | gemcitabine hydrochloride | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-148 | GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 14 | Current NDC, Legacy NDC, 2 package rows | 20240910_9f8fe5ba-943f-4f0a-9618-6083101faa28.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 |
|---|
| 68083-148-01 | 68083014801 | 1 VIAL in 1 CARTON (68083-148-01) / 5 mL in 1 VIAL | 1 vial | 2016-02-01 | 0000-00-00 | No | No | Current |