Idamycin PFS
- Product NDC
- 0013-2576
- 11-digit product format
- 000132576
- Labeler code
- 0013
- Product ID
- 0013-2576_d504ef4f-8fe8-447e-8fb3-30846fb2e486
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- idarubicin hydrochloride
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA050734
- Marketing category
- NDA
- Marketing start
- 1997-02-17
- Substance
- IDARUBICIN HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Idamycin PFS
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| IDARUBICIN HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 5VV3MDU5IE |
| Rxcui | 1791493, 1791495, 1791498, 1791499, 1791500, 1791501 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0013-2576-05 | Idamycin PFS | 1 in 1 CARTON | SOLUTION | 1 | 27 | |
| 0013-2576-05 | Idamycin PFS | 5 mL in 1 VIAL, SINGLE-DOSE | SOLUTION | 5 | 27 | |
| 0013-2576-91 | Idamycin PFS | 5 mL in 1 VIAL, SINGLE-DOSE | SOLUTION | 5 | 27 | |
| 0013-2576-91 | Idamycin PFS | 1 in 1 CARTON | SOLUTION | 1 | 27 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0013-2576-05 | ML - Milliliter | 0013-2576 | 96472a0d-92f4-4044-9ab6-f8fb968f8100 | 1 | 2024-09-09 |
| 0013-2576-91 | ML - Milliliter | 0013-2576 | c71481cd-5c0d-47d0-b3b4-bc27616473f6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| IDARUBICIN HYDROCHLORIDE | ACTIVE INGREDIENT | 5VV3MDU5IE | IDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PHARMACIA AND UPJOHN COMPANY] | 6 | |
| IDARUBICIN | ACTIVE MOIETY | ZRP63D75JW | IDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PHARMACIA AND UPJOHN COMPANY] | 6 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | IDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PHARMACIA AND UPJOHN COMPANY] | 6 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | IDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PHARMACIA AND UPJOHN COMPANY] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | IDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PHARMACIA AND UPJOHN COMPANY] | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1791499 | Idamycin 10 MG in 10 ML Injection | PSN | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791495 | Idamycin 20 MG in 20 ML Injection | PSN | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791501 | Idamycin 5 MG in 5 ML Injection | PSN | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791498 | IDArubicin HCl 10 MG in 10 ML Injection | PSN | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791493 | IDArubicin HCl 20 MG in 20 ML Injection | PSN | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791500 | IDArubicin HCl 5 MG in 5 ML Injection | PSN | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791499 | 10 ML idarubicin hydrochloride 1 MG/ML Injection [Idamycin] | SBD | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791495 | 20 ML idarubicin hydrochloride 1 MG/ML Injection [Idamycin] | SBD | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791501 | 5 ML idarubicin hydrochloride 1 MG/ML Injection [Idamycin] | SBD | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791498 | 10 ML idarubicin hydrochloride 1 MG/ML Injection | SCD | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791493 | 20 ML idarubicin hydrochloride 1 MG/ML Injection | SCD | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791500 | 5 ML idarubicin hydrochloride 1 MG/ML Injection | SCD | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791499 | 10 ML Idamycin 1 MG/ML Injection | SY | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791495 | 20 ML Idamycin 1 MG/ML Injection | SY | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791501 | 5 ML Idamycin 1 MG/ML Injection | SY | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791499 | Idamycin 10 MG per 10 ML Injection | SY | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791495 | Idamycin 20 MG per 20 ML Injection | SY | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791501 | Idamycin 5 MG per 5 ML Injection | SY | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791498 | idarubicin HCl 10 MG per 10 ML Injection | SY | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791493 | idarubicin HCl 20 MG per 20 ML Injection | SY | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
| 1791500 | idarubicin HCl 5 MG per 5 ML Injection | SY | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 27 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0013-2576-05 | 00013257605 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2576-05) / 5 mL in 1 VIAL, SINGLE-DOSE | 2024-08-12 | No | No | Historical | |
| 0013-2576-91 | 00013257691 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2576-91) / 5 mL in 1 VIAL, SINGLE-DOSE | 1997-02-17 | 2026-08-31 | No | No | Current |