Doxorubicin Hydrochloride
- Product NDC
- 0069-4037
- 11-digit product format
- 000694037
- Labeler code
- 0069
- Product ID
- 0069-4037_7de0221b-3903-4ec6-a5ba-9ede8e8a45a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxorubicin Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA050629
- Marketing category
- NDA
- Marketing start
- 2014-03-17
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0069-4037-01 | Doxorubicin Hydrochloride | 100 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 100 | 14 | |
| 0069-4037-01 | Doxorubicin Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0069-4037-01 | ML - Milliliter | 0069-4037 | 8993f8b6-acad-4234-84d6-feb26d6f8db7 | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| DOXORUBICIN HYDROCHLORIDE | ACTIVE INGREDIENT | 82F2G7BL4E | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 2 | |
| DOXORUBICIN | ACTIVE MOIETY | 80168379AG | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1790097 | DOXOrubicin HCl 10 MG in 5 mL Injection | PSN | 00634b2b-4e48-4178-8877-28582af894ad | 14 |
| 1191138 | DOXOrubicin HCl 2 MG/ML Injectable Solution | PSN | 00634b2b-4e48-4178-8877-28582af894ad | 14 |
| 1790099 | DOXOrubicin HCl 20 MG in 10 ML Injection | PSN | 00634b2b-4e48-4178-8877-28582af894ad | 14 |
| 1790100 | DOXOrubicin HCl 50 MG in 25 ML Injection | PSN | 00634b2b-4e48-4178-8877-28582af894ad | 14 |
| 1790099 | 10 ML doxorubicin hydrochloride 2 MG/ML Injection | SCD | 00634b2b-4e48-4178-8877-28582af894ad | 14 |
| 1790100 | 25 ML doxorubicin hydrochloride 2 MG/ML Injection | SCD | 00634b2b-4e48-4178-8877-28582af894ad | 14 |
| 1790097 | 5 ML doxorubicin hydrochloride 2 MG/ML Injection | SCD | 00634b2b-4e48-4178-8877-28582af894ad | 14 |
| 1191138 | doxorubicin hydrochloride 2 MG/ML Injectable Solution | SCD | 00634b2b-4e48-4178-8877-28582af894ad | 14 |
| 1790097 | doxorubicin hydrochloride 10 MG per 5 ML Injection | SY | 00634b2b-4e48-4178-8877-28582af894ad | 14 |
| 1790099 | doxorubicin hydrochloride 20 MG per 10 ML Injection | SY | 00634b2b-4e48-4178-8877-28582af894ad | 14 |
| 1790100 | doxorubicin hydrochloride 50 MG per 25 ML Injection | SY | 00634b2b-4e48-4178-8877-28582af894ad | 14 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0069-4037-01 | 00069403701 | 1 VIAL, MULTI-DOSE in 1 CARTON (0069-4037-01) > 100 mL in 1 VIAL, MULTI-DOSE | 2014-03-17 | 0000-00-00 | No | No | Current |