Dextrose
- Product NDC
- 63323-824
- 11-digit product format
- 633230824
- Labeler code
- 63323
- Product ID
- 63323-824_0591ab74-99a6-40ee-af96-80bc2ef423dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextrose Monohydrate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA209448
- Marketing category
- ANDA
- Marketing start
- 2019-03-29
- Substance
- DEXTROSE MONOHYDRATE
- Active strength
- 100 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dextrose
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROSE MONOHYDRATE | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX22YL083G |
| Rxcui | 1795477, 1795480, 1795481 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-824-24 | Dextrose | 250 mL in 1 BAG | INJECTION, SOLUTION | 250 | | 5 |
| 63323-824-25 | Dextrose | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | | 5 |
| 63323-824-26 | Dextrose | 1000 mL in 1 BAG | INJECTION, SOLUTION | 1000 | | 5 |
| 63323-824-74 | Dextrose | 30 in 1 CASE | INJECTION, SOLUTION | 30 | | 5 |
| 63323-824-75 | Dextrose | 20 in 1 CASE | INJECTION, SOLUTION | 20 | | 5 |
| 63323-824-76 | Dextrose | 10 in 1 CASE | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-824 | DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 4 | Current NDC, Legacy NDC, 6 package rows | 20220224_3b8f2692-4371-4f1a-95af-b41842131fdd.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 |
|---|
| 63323-824-24 | 63323082424 | 250 mL in 1 BAG | 250 ml | | | | | Historical |
| 63323-824-25 | 63323082425 | 500 mL in 1 BAG | 500 ml | | | | | Historical |
| 63323-824-26 | 63323082426 | 1000 mL in 1 BAG | 1000 ml | | | | | Historical |
| 63323-824-74 | 63323082474 | 30 BAG in 1 CASE (63323-824-74) / 250 mL in 1 BAG (63323-824-24) | 30 bag | 2019-03-29 | 0000-00-00 | No | No | Current |
| 63323-824-75 | 63323082475 | 20 BAG in 1 CASE (63323-824-75) / 500 mL in 1 BAG (63323-824-25) | 20 bag | 2019-03-29 | 0000-00-00 | No | No | Current |
| 63323-824-76 | 63323082476 | 10 BAG in 1 CASE (63323-824-76) / 1000 mL in 1 BAG (63323-824-26) | 10 bag | 2019-03-29 | 0000-00-00 | No | No | Current |