INFED
- Product NDC
- 52584-086
- 11-digit product format
- 525840086
- Labeler code
- 52584
- Product ID
- 52584-086_dc1d131d-b3e7-4759-b61b-fd18765201d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- iron dextran
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- General Injectables & Vaccines, Inc.
- Application
- NDA017441
- Marketing category
- NDA
- Marketing start
- 2019-01-21
- Marketing end
- 2025-01-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-086-01 | 52584008601 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-086-01) > 2 mL in 1 VIAL, SINGLE-DOSE | 2019-01-21 | 0000-00-00 | No | No | Current |