Venofer
- Product NDC
- 0517-2310
- 11-digit product format
- 005172310
- Labeler code
- 0517
- Product ID
- 0517-2310_500b09f8-36f1-4842-8d07-246fea7bdfd0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- iron sucrose
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- American Regent, Inc.
- Application
- NDA021135
- Marketing category
- NDA
- Marketing start
- 2007-06-12
- 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
- Venofer
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| IRON SUCROSE | 20 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | FZ7NYF5N8L |
| Rxcui | 1741261, 1741263, 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 |
|---|---|---|---|---|---|---|
| 0517-2310-01 | Venofer | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 45 | |
| 0517-2310-05 | Venofer | 5 in 1 BOX | INJECTION, SOLUTION | 5 | 45 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0517-2310-05 | ML - Milliliter | 0517-2310 | 4479ebb1-3743-41da-adb5-1d60eb23b0b9 | 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 [AMERICAN REGENT, INC.] | 17 | |
| FERRIC CATION | ACTIVE MOIETY | 91O4LML611 | VENOFER (IRON SUCROSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 17 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | VENOFER (IRON SUCROSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 17 |
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 | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741261 | iron (as iron sucrose) 200 MG in 10 ML Injection | PSN | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741270 | iron (as iron sucrose) 50 MG in 2.5 mL Injection | PSN | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741268 | Venofer (iron) 100 MG in 5 mL Injection | PSN | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741263 | Venofer (iron) 200 MG in 10 mL Injection | PSN | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741271 | Venofer (iron) 50 MG in 2.5 mL Injection | PSN | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741263 | 10 ML iron sucrose 20 MG/ML Injection [Venofer] | SBD | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741271 | 2.5 ML iron sucrose 20 MG/ML Injection [Venofer] | SBD | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741268 | 5 ML iron sucrose 20 MG/ML Injection [Venofer] | SBD | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741261 | 10 ML iron sucrose 20 MG/ML Injection | SCD | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741270 | 2.5 ML iron sucrose 20 MG/ML Injection | SCD | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741267 | 5 ML iron sucrose 20 MG/ML Injection | SCD | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741263 | 10 ML Venofer 20 MG/ML Injection | SY | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741271 | 2.5 ML Venofer 20 MG/ML Injection | SY | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741268 | 5 ML Venofer 20 MG/ML Injection | SY | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741267 | ferric oxide, saccharated 100 MG per 5 ML Injection | SY | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741261 | ferric oxide, saccharated 200 MG per 10 ML Injection | SY | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741270 | ferric oxide, saccharated 50 MG per 2.5 ML Injection | SY | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741267 | iron (as iron sucrose) 100 MG per 5 ML Injection | SY | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741261 | iron (as iron sucrose) 200 MG per 10 ML Injection | SY | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741270 | iron (as iron sucrose) 50 MG per 2.5 ML Injection | SY | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741268 | Venofer (iron) 100 MG per 5 ML Injection | SY | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741263 | Venofer 200 MG per 10 ML Injection | SY | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
| 1741271 | Venofer 50 MG per 2.5 ML Injection | SY | 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a | 45 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0517-2310-01 | 00517231001 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | Historical | ||||
| 0517-2310-05 | 00517231005 | 5 VIAL, SINGLE-DOSE in 1 BOX (0517-2310-05) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-2310-01) | 2007-06-12 | 0000-00-00 | No | No | Current |