DOXIL
- Product NDC
- 0338-0067
- 11-digit product format
- 003380067
- Labeler code
- 0338
- Product ID
- 0338-0067_cd847039-f8ab-4b90-ba4b-724504063f6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxorubicin hydrochloride
- Dosage form
- INJECTION, SUSPENSION, LIPOSOMAL
- Route
- INTRAVITREAL
- Labeler
- Baxter Healthcare Company
- Application
- NDA050718
- Marketing category
- NDA
- Marketing start
- 2019-08-13
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DOXIL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXORUBICIN HYDROCHLORIDE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82F2G7BL4E |
| Rxcui | 1790115, 1790127, 1790128, 1790131 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0338-0067-01 | DOXIL | 1 in 1 CARTON | INJECTION, SUSPENSION, LIPOSOMAL | 1 | | 12 |
| 0338-0067-01 | DOXIL | 25 mL in 1 VIAL, SINGLE-USE | INJECTION, SUSPENSION, LIPOSOMAL | 25 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0338-0067 | DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [BAXTER HEALTHCARE COMPANY] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250430_1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0338-0067-01 | 00338006701 | 1 VIAL, SINGLE-USE in 1 CARTON (0338-0067-01) / 25 mL in 1 VIAL, SINGLE-USE | 2019-08-13 | 0000-00-00 | No | No | Current |