AVGEMSI
- Product NDC
- 83831-124
- 11-digit product format
- 838310124
- Labeler code
- 83831
- Product ID
- 83831-124_303c41a6-c142-4cd2-b133-9e610845d5bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemcitabine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Avyxa Pharma, LLC
- Application
- NDA219920
- Marketing category
- NDA
- Marketing start
- 2025-08-03
- 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
- AVGEMSI
- 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 | 2719761, 2719763 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83831-124-01 | AVGEMSI | 52.6 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 52.6 | | 3 |
| 83831-124-01 | AVGEMSI | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83831-124-01 | 83831012401 | 1 VIAL, MULTI-DOSE in 1 CARTON (83831-124-01) / 52.6 mL in 1 VIAL, MULTI-DOSE | 2025-08-03 | No | No | Current |