MANNITOL
- Product NDC
- 51662-1468
- 11-digit product format
- 516621468
- Labeler code
- 51662
- Product ID
- 51662-1468_0ffaf004-4d61-3fd4-e063-6294a90a1a63
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MANNITOL
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- NDA016269
- Marketing category
- NDA
- Marketing start
- 2019-12-13
- 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 Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1468-1 | MANNITOL | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 50 | | 4 |
| 51662-1468-2 | MANNITOL | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 4 |
| 51662-1468-2 | MANNITOL | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 50 | | 4 |
| 51662-1468-3 | MANNITOL | 25 in 1 CASE | INJECTION, SOLUTION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1468 | MANNITOL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240129_999ce711-2d5b-0d7d-e053-2995a90a2689.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51662-1468-1 | 51662146801 | 50 mL in 1 VIAL, SINGLE-DOSE (51662-1468-1) | 50 ml | 2019-12-13 | 0000-00-00 | No | No | Current |
| 51662-1468-2 | 51662146802 | 1 in 1 POUCH | | | | | | Historical |
| 51662-1468-3 | 51662146803 | 25 POUCH in 1 CASE (51662-1468-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1468-2) / 50 mL in 1 VIAL, SINGLE-DOSE | 25 pouch | 2022-12-11 | 0000-00-00 | No | No | Current |