Venofer
- Product NDC
- 49230-534
- 11-digit product format
- 492300534
- Labeler code
- 49230
- Product ID
- 49230-534_e12cb876-ae80-416b-9bd3-a1cc83c9e666
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- iron sucrose
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Medical Care Holdings, Inc.
- Application
- NDA021135
- Marketing category
- NDA
- Marketing start
- 2008-11-04
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Venofer
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| IRON SUCROSE | 20 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | FZ7NYF5N8L |
| Rxcui | 1741267, 1741268, 1741270, 1741271 |
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 |
|---|---|---|---|---|---|---|
| 49230-534-01 | Venofer | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | 29 | |
| 49230-534-10 | Venofer | 10 in 1 BOX | INJECTION, SOLUTION | 10 | 29 | |
| 49230-534-25 | Venofer | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 29 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49230-534-10 | ML - Milliliter | 49230-534 | 56639a4a-2bb0-4ee5-8ca8-0bf68fdee0b0 | 1 | 2012-07-24 |
| 49230-534-25 | ML - Milliliter | 49230-534 | b2de4006-2fd9-49bd-96c4-3a81fe7b28bd | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| IRON SUCROSE | ACTIVE INGREDIENT | FZ7NYF5N8L | VENOFER (IRON SUCROSE) INJECTION, SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA] | 9 | |
| FERRIC CATION | ACTIVE MOIETY | 91O4LML611 | VENOFER (IRON SUCROSE) INJECTION, SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA] | 9 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | VENOFER (IRON SUCROSE) INJECTION, SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA] | 9 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1741267 | iron (as iron sucrose) 100 MG in 5 ML Injection | PSN | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741270 | iron (as iron sucrose) 50 MG in 2.5 mL Injection | PSN | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741268 | Venofer (iron) 100 MG in 5 mL Injection | PSN | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741271 | Venofer (iron) 50 MG in 2.5 mL Injection | PSN | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741271 | 2.5 ML iron sucrose 20 MG/ML Injection [Venofer] | SBD | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741268 | 5 ML iron sucrose 20 MG/ML Injection [Venofer] | SBD | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741270 | 2.5 ML iron sucrose 20 MG/ML Injection | SCD | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741267 | 5 ML iron sucrose 20 MG/ML Injection | SCD | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741271 | 2.5 ML Venofer 20 MG/ML Injection | SY | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741268 | 5 ML Venofer 20 MG/ML Injection | SY | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741267 | ferric oxide, saccharated 100 MG per 5 ML Injection | SY | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741270 | ferric oxide, saccharated 50 MG per 2.5 ML Injection | SY | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741267 | iron (as iron sucrose) 100 MG per 5 ML Injection | SY | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741270 | iron (as iron sucrose) 50 MG per 2.5 ML Injection | SY | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741268 | Venofer (iron) 100 MG per 5 ML Injection | SY | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
| 1741271 | Venofer 50 MG per 2.5 ML Injection | SY | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 | 29 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49230-534-01 | 49230053401 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | Historical | ||||
| 49230-534-10 | 49230053410 | 10 VIAL, SINGLE-DOSE in 1 BOX (49230-534-10) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01) | 2008-11-04 | 0000-00-00 | No | No | Current | |
| 49230-534-25 | 49230053425 | 25 VIAL, SINGLE-DOSE in 1 TRAY (49230-534-25) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01) | 2008-11-04 | 0000-00-00 | No | No | Current |