OXDERYS
- Product NDC
- 83831-162
- Requested package NDC
- 83831-162-80
- 11-digit product format
- 838310162
- Labeler code
- 83831
- Product ID
- 83831-162_8b424003-eef2-4eba-a3d1-e1c6c2d9047b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxorubicin Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Avyxa Pharma, LLC
- Application
- NDA221093
- Marketing category
- NDA
- Marketing start
- 2026-11-09
- Substance
- DOXORUBICIN HYDROCHLORIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OXDERYS
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXORUBICIN HYDROCHLORIDE | 2 mg/mL |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83831-162-80 | 83831016280 | 1 VIAL, MULTI-DOSE in 1 CARTON (83831-162-80) / 80 mL in 1 VIAL, MULTI-DOSE | 2026-11-09 | No | No | Current |