Prescription drug · ANDA
Dextrose Monohydrate NDC 76329-3302
Dextrose monohydrate 25 g/50mL · Injection, Solution · Intravenous · International Medication Systems, Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76329-3302-1 | 76329330201 | 1 SYRINGE in 1 CARTON (76329-3302-1) / 50 mL in 1 SYRINGEMarketed from Nov 11, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Monohydrate
- Generic name (nonproprietary)
- dextrose monohydrate
- Active ingredients
- Dextrose monohydrate — 25 g/50mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203451
- Marketing start
- Listing expires
- Identifiers
- Product ID 76329-3302_45b366a9-6c0c-4643-9951-4ff880b29c83SPL ID 45b366a9-6c0c-4643-9951-4ff880b29c83SPL set ID fcc7ac79-cd70-4f03-a4de-f051f9ca1f7dRxCUI 727517UNII 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
N476329330201followed by a unit qualifier and the quantityPackage 76329-3302-01. 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)
INDICATIONS AND USAGE 50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to ensure proper utilization of dextrose and avoid production of hyperglycemia.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203451
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 |
|---|---|---|---|---|
| Dextrose monohydrate | Dextrose monohydrate 25 g/50mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1584 |
| Dextrose Monohydrate | Dextrose monohydrate 25 g/50mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7282 |