Iron Sucrose
- Product NDC
- 76329-9202
- 11-digit product format
- 763299202
- Labeler code
- 76329
- Product ID
- 76329-9202_8fa02679-e3f5-44d2-b074-7003d6cf070b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Iron Sucrose
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- International Medication Systems, Limited
- Application
- ANDA208977
- Marketing category
- ANDA
- Marketing start
- 2025-09-12
- Substance
- IRON SUCROSE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Iron Sucrose
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| IRON SUCROSE | 20 mg/mL |
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76329-9202-5 | ML - Milliliter | 76329-9202 | 8993a0b2-4570-42e0-bcc8-cf2480a48147 | 1 | 2025-09-12 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1741267 | iron (as iron sucrose) 100 MG in 5 ML Injection | PSN | 6f19c80e-22e9-4bab-aa53-4d2d958119ed | 4 |
| 1741261 | iron (as iron sucrose) 200 MG in 10 ML Injection | PSN | 6f19c80e-22e9-4bab-aa53-4d2d958119ed | 4 |
| 1741270 | iron (as iron sucrose) 50 MG in 2.5 mL Injection | PSN | 6f19c80e-22e9-4bab-aa53-4d2d958119ed | 4 |
| 1741261 | 10 ML iron sucrose 20 MG/ML Injection | SCD | 6f19c80e-22e9-4bab-aa53-4d2d958119ed | 4 |
| 1741270 | 2.5 ML iron sucrose 20 MG/ML Injection | SCD | 6f19c80e-22e9-4bab-aa53-4d2d958119ed | 4 |
| 1741267 | 5 ML iron sucrose 20 MG/ML Injection | SCD | 6f19c80e-22e9-4bab-aa53-4d2d958119ed | 4 |
| 1741267 | ferric oxide, saccharated 100 MG per 5 ML Injection | SY | 6f19c80e-22e9-4bab-aa53-4d2d958119ed | 4 |
| 1741261 | ferric oxide, saccharated 200 MG per 10 ML Injection | SY | 6f19c80e-22e9-4bab-aa53-4d2d958119ed | 4 |
| 1741270 | ferric oxide, saccharated 50 MG per 2.5 ML Injection | SY | 6f19c80e-22e9-4bab-aa53-4d2d958119ed | 4 |
| 1741267 | iron (as iron sucrose) 100 MG per 5 ML Injection | SY | 6f19c80e-22e9-4bab-aa53-4d2d958119ed | 4 |
| 1741261 | iron (as iron sucrose) 200 MG per 10 ML Injection | SY | 6f19c80e-22e9-4bab-aa53-4d2d958119ed | 4 |
| 1741270 | iron (as iron sucrose) 50 MG per 2.5 ML Injection | SY | 6f19c80e-22e9-4bab-aa53-4d2d958119ed | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 76329-9202-5 | 76329920205 | 5 VIAL, SINGLE-DOSE in 1 PACKAGE (76329-9202-5) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-09-12 | No | No | Current |