Iron Sucrose
- Product NDC
- 0781-3487
- 11-digit product format
- 007813487
- Labeler code
- 0781
- Product ID
- 0781-3487_78c04f10-0489-4e45-8cb5-28a6789d1149
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Iron Sucrose
- Dosage form
- INJECTION
- Route
- INTRAVITREAL
- Labeler
- Sandoz Inc
- Application
- ANDA212340
- Marketing category
- ANDA
- Marketing start
- 2025-09-22
- Substance
- IRON SUCROSE
- Active strength
- 200 mg/10mL
- 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
- Iron Sucrose
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| IRON SUCROSE | 200 mg/10mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | FZ7NYF5N8L |
| Rxcui | 1741261, 1741267, 1741270 |
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 |
|---|---|---|---|---|---|---|
| 0781-3487-14 | Iron Sucrose | 5 in 1 CARTON | INJECTION | 5 | 1 | |
| 0781-3487-70 | Iron Sucrose | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | 1 | |
| 0781-3487-92 | Iron Sucrose | 10 in 1 CARTON | INJECTION | 10 | 1 | |
| 0781-3487-92 | Iron Sucrose | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | 1 | |
| 0781-3487-94 | Iron Sucrose | 1 in 1 CARTON | INJECTION | 1 | 1 | |
| 0781-3487-94 | Iron Sucrose | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-3487-14 | ML - Milliliter | 0781-3487 | e5f030a6-e74c-46a3-8928-4ec052185b36 | 1 | 2025-10-14 |
| 0781-3487-70 | ML - Milliliter | 0781-3487 | aa1b8155-84b4-40ee-9f41-edc9ecdd86a7 | 1 | 2025-10-14 |
| 0781-3487-94 | ML - Milliliter | 0781-3487 | 6895b076-957e-44cd-8895-62bf92fca08f | 1 | 2025-10-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1741267 | iron (as iron sucrose) 100 MG in 5 ML Injection | PSN | 78c04f10-0489-4e45-8cb5-28a6789d1149 | 1 |
| 1741261 | iron (as iron sucrose) 200 MG in 10 ML Injection | PSN | 78c04f10-0489-4e45-8cb5-28a6789d1149 | 1 |
| 1741270 | iron (as iron sucrose) 50 MG in 2.5 mL Injection | PSN | 78c04f10-0489-4e45-8cb5-28a6789d1149 | 1 |
| 1741261 | 10 ML iron sucrose 20 MG/ML Injection | SCD | 78c04f10-0489-4e45-8cb5-28a6789d1149 | 1 |
| 1741270 | 2.5 ML iron sucrose 20 MG/ML Injection | SCD | 78c04f10-0489-4e45-8cb5-28a6789d1149 | 1 |
| 1741267 | 5 ML iron sucrose 20 MG/ML Injection | SCD | 78c04f10-0489-4e45-8cb5-28a6789d1149 | 1 |
| 1741267 | ferric oxide, saccharated 100 MG per 5 ML Injection | SY | 78c04f10-0489-4e45-8cb5-28a6789d1149 | 1 |
| 1741261 | ferric oxide, saccharated 200 MG per 10 ML Injection | SY | 78c04f10-0489-4e45-8cb5-28a6789d1149 | 1 |
| 1741270 | ferric oxide, saccharated 50 MG per 2.5 ML Injection | SY | 78c04f10-0489-4e45-8cb5-28a6789d1149 | 1 |
| 1741267 | iron (as iron sucrose) 100 MG per 5 ML Injection | SY | 78c04f10-0489-4e45-8cb5-28a6789d1149 | 1 |
| 1741261 | iron (as iron sucrose) 200 MG per 10 ML Injection | SY | 78c04f10-0489-4e45-8cb5-28a6789d1149 | 1 |
| 1741270 | iron (as iron sucrose) 50 MG per 2.5 ML Injection | SY | 78c04f10-0489-4e45-8cb5-28a6789d1149 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0781-3487-14 | 00781348714 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0781-3487-14) / 10 mL in 1 VIAL, SINGLE-DOSE (0781-3487-70) | 2025-09-22 | No | No | Current | |
| 0781-3487-70 | 00781348770 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | Historical | |||
| 0781-3487-92 | 00781348792 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3487-92) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-09-22 | No | No | Current | |
| 0781-3487-94 | 00781348794 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3487-94) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-09-22 | No | No | Current |