Mannitol
- Product NDC
- 0404-9905
- 11-digit product format
- 004049905
- Labeler code
- 0404
- Product ID
- 0404-9905_f3bb5de6-286d-4efc-a55d-e0b65dc4b1c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mannitol
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- NDA016269
- Marketing category
- NDA
- Marketing start
- 2022-01-12
- Substance
- MANNITOL
- Active strength
- 12.5 g/50mL
- Pharmacologic classes
- Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mannitol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MANNITOL | 12.5 g/50mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3OWL53L36A |
| Rxcui | 311450 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9905-50 | Mannitol | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 50 | | 6 |
| 0404-9905-50 | Mannitol | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9905 | MANNITOL INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250522_e2444db1-9dfe-451f-a33c-9b00786464d2.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 |
|---|
| 0404-9905-50 | 00404990550 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9905-50) / 50 mL in 1 VIAL, SINGLE-DOSE | 2022-01-12 | 0000-00-00 | No | No | Current |