Injectafer
- Product NDC
- 0517-0602
- 11-digit product format
- 005170602
- Labeler code
- 0517
- Product ID
- 0517-0602_a092ebb6-505b-464f-9669-194a913ff8e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ferric Carboxymaltose Injection
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- American Regent, Inc.
- Application
- NDA203565
- Marketing category
- NDA
- Marketing start
- 2022-06-01
- Substance
- FERRIC CARBOXYMALTOSE
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Injectafer
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FERRIC CARBOXYMALTOSE | 50 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 6897GXD6OE |
| Rxcui | 1435169, 1435174, 2552400, 2552401, 2602296, 2602297 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 04cdd491-d111-4bc2-9549-75c575e1bd4b | Product name | 1 | 20200714 |
| 8390fb8b-6c75-416c-a9a1-70e8ed493b73 | Product name | 1 | 20200611 |
| 96a528e9-23e2-495f-81b9-ae87df2f7552 | Product name | 1 | 20191120 |
| 3df56c93-5837-4523-aac2-4b1ec48b9676 | Product name | 2 | 20160719 |
| a883b7cc-d320-41d7-92ae-c873457ae641 | Product name | 1 | 20151116 |
| bb23e78e-9e64-4037-a1c1-0e1d8762700e | Product name | 1 | 20150325 |
| ef06c001-572c-d95e-42f6-ee83da75673a | Product name | 1 | 20140508 |
| fd21f957-6863-d07b-5a35-250186878716 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0517-0602-01 | Injectafer | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 29 | |
| 0517-0602-01 | Injectafer | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | 29 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0517-0602-01 | ML - Milliliter | 0517-0602 | 5b25ca95-5457-4a29-b317-dafeeffbd95d | 1 | 2022-08-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FERRIC CARBOXYMALTOSE | ACTIVE INGREDIENT | 6897GXD6OE | INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 3 | |
| FERRIC CATION | ACTIVE MOIETY | 91O4LML611 | INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0517-0602 | INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION INJECTAFER (FERRIC CARBOXYMALTOSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 29 | Current NDC, Legacy NDC, 2 package rows | 20250108_517b4a19-45b3-4286-9f6a-ced4e10447de.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1435169 | ferric carboxymaltose (as iron) 750 MG in 15 mL Injection | PSN | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 2552400 | ferric carboxymaltose (iron) 1000 MG in 20 mL Injection | PSN | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 2602296 | ferric carboxymaltose 100 MG in 2 ML Injection | PSN | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 2602297 | Injectafer (iron) 100 MG in 2 mL Injection | PSN | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 2552401 | Injectafer (iron) 1000 MG in 20 ML Injection | PSN | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 1435174 | Injectafer (iron) 750 MG in 15 mL Injection | PSN | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 1435174 | 15 ML ferric carboxymaltose 50 MG/ML Injection [Injectafer] | SBD | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 2602297 | 2 ML ferric carboxymaltose 50 MG/ML Injection [Injectafer] | SBD | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 2552401 | 20 ML ferric carboxymaltose 50 MG/ML Injection [Injectafer] | SBD | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 1435169 | 15 ML ferric carboxymaltose 50 MG/ML Injection | SCD | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 2602296 | 2 ML ferric carboxymaltose 50 MG/ML Injection | SCD | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 2552400 | 20 ML ferric carboxymaltose 50 MG/ML Injection | SCD | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 1435174 | 15 ML Injectafer 50 MG/ML Injection | SY | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 2602297 | 2 ML Injectafer 50 MG/ML Injection | SY | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 2552401 | 20 ML Injectafer 50 MG/ML Injection | SY | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 2552400 | ferric carboxymaltose (as elemental iron) 1000 MG per 20 ML Injection | SY | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 1435169 | ferric carboxymaltose (as elemental iron) 750 MG per 15 ML Injection | SY | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 2602296 | ferric carboxymaltose 100 MG per 2 ML Injection | SY | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 2552401 | Injectafer (as elemental iron) 1000 MG per 20 ML Injection | SY | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
| 1435174 | Injectafer (as elemental iron) 750 MG per 15 ML Injection | SY | 517b4a19-45b3-4286-9f6a-ced4e10447de | 29 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0517-0602-01 | 00517060201 | 1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01) / 2 mL in 1 VIAL, SINGLE-DOSE | 2022-07-28 | 0000-00-00 | No | No | Current |