Mannitol
- Product NDC
- 52584-031
- 11-digit product format
- 525840031
- Labeler code
- 52584
- Product ID
- 52584-031_23fbdef9-7b67-431e-80e7-0bc781e38975
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mannitol
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- General Injectables & Vaccines, Inc
- Application
- NDA016269
- Marketing category
- NDA
- Marketing start
- 2019-11-19
- Marketing end
- 2023-12-01
- Substance
- MANNITOL
- Active strength
- 13 g/50mL
- Pharmacologic classes
- Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]
- 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 |
|---|
| 52584-031-01 | 52584003101 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-031-01) > 50 mL in 1 VIAL, SINGLE-DOSE | 2019-11-19 | 2023-12-01 | No | No | Current |