daunorubicin hydrochloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines, Inc.. The primary component is Daunorubicin Hydrochloride.
| Product ID | 0703-5233_78928bf7-c736-4d9a-8137-a0a5c0653540 |
| NDC | 0703-5233 |
| Product Type | Human Prescription Drug |
| Proprietary Name | daunorubicin hydrochloride |
| Generic Name | Daunorubicin Hydrochloride |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2004-04-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA065035 |
| Labeler Name | Teva Parenteral Medicines, Inc. |
| Substance Name | DAUNORUBICIN HYDROCHLORIDE |
| Active Ingredient Strength | 5 mg/mL |
| Pharm Classes | Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2004-04-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA065035 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-04-01 |
| Marketing Category | ANDA |
| Application Number | ANDA065035 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-04-01 |
| Marketing End Date | 2016-06-30 |
| Marketing Category | ANDA |
| Application Number | ANDA065035 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-04-01 |
| Marketing End Date | 2016-06-30 |
| Marketing Category | ANDA |
| Application Number | ANDA065035 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-04-01 |
| Ingredient | Strength |
|---|---|
| DAUNORUBICIN HYDROCHLORIDE | 5 mg/mL |
| SPL SET ID: | 29fe455e-f177-4b0e-99fb-60a53016db72 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9550 | Daunorubicin Hydrochloride | Daunorubicin Hydrochloride |
| 0143-9551 | Daunorubicin Hydrochloride | Daunorubicin Hydrochloride |
| 0703-5233 | daunorubicin hydrochloride | daunorubicin hydrochloride |
| 42658-019 | Daunorubicin Hydrochloride | daunorubicin hydrochloride |
| 42658-021 | Daunorubicin Hydrochloride | daunorubicin hydrochloride |