Dextrose
- Product NDC
- 65219-460
- 11-digit product format
- 652190460
- Labeler code
- 65219
- Product ID
- 65219-460_efc3b0c9-518a-47db-bb3e-ebdfd4646e9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextrose Monohydrate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- FRESENIUS KABI USA, LLC
- Application
- ANDA207449
- Marketing category
- ANDA
- Marketing start
- 2024-07-09
- Substance
- DEXTROSE MONOHYDRATE
- Active strength
- 50 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dextrose
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROSE MONOHYDRATE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX22YL083G |
| Rxcui | 1795607, 1795609, 1795610, 1795612, 1795616 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-460-05 | Dextrose | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | | 1 |
| 65219-460-20 | Dextrose | 20 in 1 CASE | INJECTION, SOLUTION | 20 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-460 | DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, 2 package rows | 20240828_576a22d8-5f2f-497e-80ad-1842ca74bb53.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-460-05 | 65219046005 | 500 mL in 1 BAG | 500 ml | | | | Historical |
| 65219-460-20 | 65219046020 | 20 BAG in 1 CASE (65219-460-20) / 500 mL in 1 BAG (65219-460-05) | 20 bag | 2024-07-09 | No | No | Current |