Venofer
- Product NDC
- 0517-2340
- 11-digit product format
- 005172340
- Labeler code
- 0517
- Product ID
- 0517-2340_215e70bd-ace6-4a58-a31f-ca899ec2eca5
- 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
- 2014-07-14
- 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 | 1741267, 1741268 |
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 |
|---|---|---|---|---|---|---|
| 0517-2340-01 | Venofer | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 45 | |
| 0517-2340-01 | Venofer | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | 45 | |
| 0517-2340-10 | Venofer | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | 45 | |
| 0517-2340-10 | Venofer | 10 in 1 BOX | INJECTION, SOLUTION | 10 | 45 | |
| 0517-2340-25 | Venofer | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 45 | |
| 0517-2340-25 | Venofer | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | 45 | |
| 0517-2340-99 | Venofer | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 12 | |
| 0517-2340-99 | Venofer | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0517-2340-01 | ML - Milliliter | 0517-2340 | c83033c5-92cb-4bda-a9b9-21c4e7f18be5 | 1 | 2021-03-02 |
| 0517-2340-10 | ML - Milliliter | 0517-2340 | 73964943-e4f4-4581-b061-fc8b0188534c | 1 | 2012-07-24 |
| 0517-2340-25 | ML - Milliliter | 0517-2340 | a5a489f7-3b6e-4d1c-a308-a291a3b83118 | 1 | 2012-07-24 |
| 0517-2340-99 | ML - Milliliter | 0517-2340 | c1603439-6711-4391-8bff-d8c162fc2d10 | 1 | 2014-08-01 |
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#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0517-2340 | VENOFER (IRON SUCROSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 44 | Current NDC, Legacy NDC, 6 package rows | 20240904_626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a.zip |
| 0517-2340 | VENOFER (IRON SUCROSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240904_b998ef36-81fa-40a1-9cd1-6d6156f91564.zip |
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 |
| 1741267 | iron (as iron sucrose) 100 MG in 5 ML Injection | PSN | b998ef36-81fa-40a1-9cd1-6d6156f91564 | 12 |
| 1741268 | Venofer (iron) 100 MG in 5 mL Injection | PSN | b998ef36-81fa-40a1-9cd1-6d6156f91564 | 12 |
| 1741268 | 5 ML iron sucrose 20 MG/ML Injection [Venofer] | SBD | b998ef36-81fa-40a1-9cd1-6d6156f91564 | 12 |
| 1741267 | 5 ML iron sucrose 20 MG/ML Injection | SCD | b998ef36-81fa-40a1-9cd1-6d6156f91564 | 12 |
| 1741268 | 5 ML Venofer 20 MG/ML Injection | SY | b998ef36-81fa-40a1-9cd1-6d6156f91564 | 12 |
| 1741267 | ferric oxide, saccharated 100 MG per 5 ML Injection | SY | b998ef36-81fa-40a1-9cd1-6d6156f91564 | 12 |
| 1741267 | iron (as iron sucrose) 100 MG per 5 ML Injection | SY | b998ef36-81fa-40a1-9cd1-6d6156f91564 | 12 |
| 1741268 | Venofer (iron) 100 MG per 5 ML Injection | SY | b998ef36-81fa-40a1-9cd1-6d6156f91564 | 12 |
| 1741267 | iron (as iron sucrose) 100 MG in 5 ML Injection | PSN | fb5f2539-f1ac-44a1-b899-66802576c674 | 5 |
| 1741268 | Venofer (iron) 100 MG in 5 mL Injection | PSN | fb5f2539-f1ac-44a1-b899-66802576c674 | 5 |
| 1741268 | 5 ML iron sucrose 20 MG/ML Injection [Venofer] | SBD | fb5f2539-f1ac-44a1-b899-66802576c674 | 5 |
| 1741267 | 5 ML iron sucrose 20 MG/ML Injection | SCD | fb5f2539-f1ac-44a1-b899-66802576c674 | 5 |
| 1741268 | 5 ML Venofer 20 MG/ML Injection | SY | fb5f2539-f1ac-44a1-b899-66802576c674 | 5 |
| 1741267 | ferric oxide, saccharated 100 MG per 5 ML Injection | SY | fb5f2539-f1ac-44a1-b899-66802576c674 | 5 |
| 1741267 | iron (as iron sucrose) 100 MG per 5 ML Injection | SY | fb5f2539-f1ac-44a1-b899-66802576c674 | 5 |
| 1741268 | Venofer (iron) 100 MG per 5 ML Injection | SY | fb5f2539-f1ac-44a1-b899-66802576c674 | 5 |
| 1741267 | iron (as iron sucrose) 100 MG in 5 ML Injection | PSN | c59cb54c-bee5-96d6-e053-2995a90a767c | 2 |
| 1741267 | 5 ML iron sucrose 20 MG/ML Injection | SCD | c59cb54c-bee5-96d6-e053-2995a90a767c | 2 |
| 1741267 | ferric oxide, saccharated 100 MG per 5 ML Injection | SY | c59cb54c-bee5-96d6-e053-2995a90a767c | 2 |
| 1741267 | iron (as iron sucrose) 100 MG per 5 ML Injection | SY | c59cb54c-bee5-96d6-e053-2995a90a767c | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0517-2340-01 | 00517234001 | 1 VIAL, SINGLE-DOSE in 1 BOX (0517-2340-01) / 5 mL in 1 VIAL, SINGLE-DOSE | 2000-11-10 | 0000-00-00 | No | No | Current |
| 0517-2340-10 | 00517234010 | 10 VIAL, SINGLE-DOSE in 1 BOX (0517-2340-10) / 5 mL in 1 VIAL, SINGLE-DOSE | 2000-11-10 | 0000-00-00 | No | No | Current |
| 0517-2340-25 | 00517234025 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2340-25) / 5 mL in 1 VIAL, SINGLE-DOSE | 2000-11-10 | 0000-00-00 | No | No | Current |
| 0517-2340-99 | 00517234099 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0517-2340-99) / 5 mL in 1 VIAL, SINGLE-DOSE | 2014-07-14 | 0000-00-00 | No | No | Current |