INFED
- Product NDC
- 0404-9879
- 11-digit product format
- 004049879
- Labeler code
- 0404
- Product ID
- 0404-9879_6dc448fd-d581-4cdb-a4a5-818a41f60c23
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- iron dextran
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- NDA017441
- Marketing category
- NDA
- Marketing start
- 2022-01-11
- Substance
- IRON DEXTRAN
- Active strength
- 50 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
- INFED
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IRON DEXTRAN | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 95HR524N2M |
| Rxcui | 206216, 311144 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9879-02 | INFED | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 7 |
| 0404-9879-02 | INFED | 1 in 1 BAG | INJECTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9879 | INFED (IRON DEXTRAN) INJECTION [HENRY SCHEIN, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241016_99bf34be-cb8a-46d1-9637-5544dc2da287.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9879-02 | 00404987902 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9879-02) / 2 mL in 1 VIAL, SINGLE-DOSE | 2022-01-11 | 0000-00-00 | No | No | Current |