Prescription drug · ANDA
Dextrose (Dextrose monohydrate) NDC 63323-824
Dextrose monohydrate 100 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-824-74 | 6332308247463323082474 | 30 BAG in 1 CASE (63323-824-74) / 250 mL in 1 BAG (63323-824-24)Marketed from Mar 29, 2019 | |
| 63323-824-75 | 6332308247563323082475 | 20 BAG in 1 CASE (63323-824-75) / 500 mL in 1 BAG (63323-824-25)Marketed from Mar 29, 2019 | |
| 63323-824-76 | 6332308247663323082476 | 10 BAG in 1 CASE (63323-824-76) / 1000 mL in 1 BAG (63323-824-26)Marketed from Mar 29, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Dextrose
- Generic name (nonproprietary)
- dextrose monohydrate
- Active ingredients
- Dextrose monohydrate — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209448
- Marketing start
- Listing expires
- Identifiers
- Product ID 63323-824_0591ab74-99a6-40ee-af96-80bc2ef423dcSPL ID 0591ab74-99a6-40ee-af96-80bc2ef423dcSPL set ID 3b8f2692-4371-4f1a-95af-b41842131fddRxCUI 1795477, 1795480, 1795481UNII LX22YL083G
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N463323082474followed by a unit qualifier and the quantityPackage 63323-0824-74. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Dextrose Injection is indicated as source of water and calories. Dextrose Injection is indicated as a source of water and calories. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 63323-824
- What is NDC 63323-824?
- 63323-824 is the product NDC for Dextrose (dextrose monohydrate), Dextrose monohydrate 100 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dextrose (Dextrose Monohydrate).
- What is the active ingredient?
- Dextrose monohydrate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dextrose?
- 69 other product NDCs are listed under this name. See all Dextrose NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dextrose products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dextrosedextrose monohydrate | Dextrose monohydrate 250 mg/mL | Injection, SolutionIntravenous | REMEDYREPACK INC. | 70518-4452 | 70518-4452-00 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 25 g/50mL | Injection, SolutionIntravenous | REMEDYREPACK INC. | 70518-4219 | 70518-4219-00 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 50 mg/mL | Injection, SolutionIntravenous | FRESENIUS KABI USA, LLC | 65219-456 | 65219-0456-60 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 50 mg/mL | Injection, SolutionIntravenous | FRESENIUS KABI USA, LLC | 65219-458 | 65219-0458-30 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 50 mg/mL | Injection, SolutionIntravenous | FRESENIUS KABI USA, LLC | 65219-460 | 65219-0460-20 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 50 mg/mL | Injection, SolutionIntravenous | FRESENIUS KABI USA, LLC | 65219-462 | 65219-0462-10 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 50 mg/mL | Injection, SolutionIntravenous | FRESENIUS KABI USA, LLC | 65219-464 | 65219-0464-50 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 50 mg/mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-460 | 84549-0460-20 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 25 g/50mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9845 | 00404-9845-50 |
| Dextrosedextrose monohydrate | Dextrose monohydrate 25 g/50mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9847 | 00404-9847-50 |
Other NDCs under ANDA 209448
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dextrosedextrose monohydrate | Dextrose monohydrate 100 mg/mL | Injection, SolutionIntravenous | Becton Dickinson and Company | 17271-721 |
| Dextrose | Dextrose monohydrate 100 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co. LLC. DBA HealthFirst | 51662-1680 |