Adriamycin
- Product NDC
- 0143-9369
- 11-digit product format
- 001439369
- Labeler code
- 0143
- Product ID
- 0143-9369_64517d03-d04d-40ed-8627-afcae0b156bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxorubicin Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA062975
- Marketing category
- ANDA
- Marketing start
- 1996-05-01
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2ee64805-1a32-49b4-a119-9376fc9e6633 | Product name | 5 | 20250305 |
| 750deab0-bb49-36cc-d493-bfaec857a32e | Product name | 5 | 20190807 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0143-9369-01 | 2026-01-29 | C162847 | 48780-1 | 49896155-aa40-586f-e063-e6dba90add90 | These highlights do not include all the information needed to use ADRIAMYCIN (DOXOrubicin HCl) safely and effectively. See full prescribing information for ADRIAMYCIN ( Doxorubicin HCl) . ADRIAMYCIN (DOXOrubicin HCl) Injection, USP, for intravenous use Initial U.S. Approval: 1974 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-9369-01 | Adriamycin | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 3 | |
| 0143-9369-01 | Adriamycin | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-9369-01 | ML - Milliliter | 0143-9369 | bc54baf4-a35c-44ef-8e60-1678e6225dfa | 1 | 2020-03-10 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1799305 | ADRIAMYCIN 10 MG in 5 ML Injection | PSN | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1799310 | ADRIAMYCIN 2 MG/ML Injectable Solution | PSN | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1799308 | ADRIAMYCIN 20 MG in 10 ML Injection | PSN | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1799307 | ADRIAMYCIN 50 MG in 25 ML Injection | PSN | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1790097 | DOXOrubicin HCl 10 MG in 5 mL Injection | PSN | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1191138 | DOXOrubicin HCl 2 MG/ML Injectable Solution | PSN | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1790099 | DOXOrubicin HCl 20 MG in 10 ML Injection | PSN | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1790100 | DOXOrubicin HCl 50 MG in 25 ML Injection | PSN | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1799308 | 10 ML doxorubicin hydrochloride 2 MG/ML Injection [Adriamycin] | SBD | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1799307 | 25 ML doxorubicin hydrochloride 2 MG/ML Injection [Adriamycin] | SBD | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1799305 | 5 ML doxorubicin hydrochloride 2 MG/ML Injection [Adriamycin] | SBD | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1799310 | doxorubicin hydrochloride 2 MG/ML Injectable Solution [Adriamycin] | SBD | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1790099 | 10 ML doxorubicin hydrochloride 2 MG/ML Injection | SCD | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1790100 | 25 ML doxorubicin hydrochloride 2 MG/ML Injection | SCD | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1790097 | 5 ML doxorubicin hydrochloride 2 MG/ML Injection | SCD | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1191138 | doxorubicin hydrochloride 2 MG/ML Injectable Solution | SCD | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1799305 | 5 ML Adriamycin 2 MG/ML Injection | SY | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1799310 | Adriamycin 2 MG/ML Injectable Solution | SY | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1799308 | ADRIAMYCIN 20 MG per 10 ML Injection | SY | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1799307 | ADRIAMYCIN 50 MG per 25 ML Injection | SY | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1790097 | doxorubicin hydrochloride 10 MG per 5 ML Injection | SY | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1790099 | doxorubicin hydrochloride 20 MG per 10 ML Injection | SY | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
| 1790100 | doxorubicin hydrochloride 50 MG per 25 ML Injection | SY | b05d7515-2179-4f4b-b37e-dccc77127f8f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0143-9369-01 | 00143936901 | 1 VIAL in 1 BOX (0143-9369-01) > 5 mL in 1 VIAL | 1 vial | 2019-10-01 | 0000-00-00 | No | No | Current |