Adriamycin
- Product NDC
- 0143-9546
- 11-digit product format
- 001439546
- Labeler code
- 0143
- Product ID
- 0143-9546_7eb88b4b-34e3-4d47-80f4-f17bd690d3b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxorubicin Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA064097
- 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#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0143-9546-01 | 2026-01-29 | C162847 | 48780-1 | 49896155-a1b3-586f-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 |
|---|---|---|---|---|---|---|
| 0143-9546-01 | Adriamycin | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 10 | |
| 0143-9546-01 | Adriamycin | 100 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 100 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-9546-01 | ML - Milliliter | 0143-9546 | 753dfebf-cafb-4543-b0aa-0d51e1b4d79e | 1 | 2016-12-07 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1799305 | ADRIAMYCIN 10 MG in 5 ML Injection | PSN | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1799310 | ADRIAMYCIN 2 MG/ML Injectable Solution | PSN | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1799308 | ADRIAMYCIN 20 MG in 10 ML Injection | PSN | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1799307 | ADRIAMYCIN 50 MG in 25 ML Injection | PSN | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1790097 | DOXOrubicin HCl 10 MG in 5 mL Injection | PSN | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1191138 | DOXOrubicin HCl 2 MG/ML Injectable Solution | PSN | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1790099 | DOXOrubicin HCl 20 MG in 10 ML Injection | PSN | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1790100 | DOXOrubicin HCl 50 MG in 25 ML Injection | PSN | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1799308 | 10 ML doxorubicin hydrochloride 2 MG/ML Injection [Adriamycin] | SBD | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1799307 | 25 ML doxorubicin hydrochloride 2 MG/ML Injection [Adriamycin] | SBD | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1799305 | 5 ML doxorubicin hydrochloride 2 MG/ML Injection [Adriamycin] | SBD | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1799310 | doxorubicin hydrochloride 2 MG/ML Injectable Solution [Adriamycin] | SBD | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1790099 | 10 ML doxorubicin hydrochloride 2 MG/ML Injection | SCD | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1790100 | 25 ML doxorubicin hydrochloride 2 MG/ML Injection | SCD | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1790097 | 5 ML doxorubicin hydrochloride 2 MG/ML Injection | SCD | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1191138 | doxorubicin hydrochloride 2 MG/ML Injectable Solution | SCD | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1799305 | 5 ML Adriamycin 2 MG/ML Injection | SY | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1799310 | Adriamycin 2 MG/ML Injectable Solution | SY | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1799308 | ADRIAMYCIN 20 MG per 10 ML Injection | SY | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1799307 | ADRIAMYCIN 50 MG per 25 ML Injection | SY | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1790097 | doxorubicin hydrochloride 10 MG per 5 ML Injection | SY | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1790099 | doxorubicin hydrochloride 20 MG per 10 ML Injection | SY | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
| 1790100 | doxorubicin hydrochloride 50 MG per 25 ML Injection | SY | 0f153c1e-efce-4276-8273-d9e4c8455d16 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0143-9546-01 | 00143954601 | 1 VIAL, MULTI-DOSE in 1 BOX (0143-9546-01) > 100 mL in 1 VIAL, MULTI-DOSE | 1996-05-01 | 0000-00-00 | No | No | Current |