Venofer
- Product NDC
- 50090-4541
- 11-digit product format
- 500904541
- Labeler code
- 50090
- Product ID
- 50090-4541_64b0125a-f5f0-4180-8636-6914dd79d6d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- iron sucrose
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- A-S Medication Solutions
- Application
- NDA021135
- Marketing category
- NDA
- Marketing start
- 2000-11-10
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4541-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-05a3-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use VENOFER ® safely and effectively. See full prescribing information for VENOFER. Venofer (iron sucrose) injection, for intravenous use Initial U.S. Approval: 2000 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4541-0 | Venofer | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 5 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-4541-0 | ML - Milliliter | 50090-4541 | 39a4651e-63e6-4252-9bf6-34e86eb9a615 | 1 | 2022-07-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4541 | VENOFER (IRON SUCROSE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 5 | Legacy NDC, 1 package rows | 20210417_fb5f2539-f1ac-44a1-b899-66802576c674.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-4541-0 | 50090454100 | 5 mL in 1 VIAL, SINGLE-USE (50090-4541-0) | 5 ml | 2019-09-20 | 0000-00-00 | No | No | Current |