Prescription drug · ANDA
Desmopressin Acetate NDC 39822-6250
Desmopressin acetate 4 ug/mL · Injection, Solution · Intravenous, Subcutaneous · XGen Pharmaceuticals DJB, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 39822-6250-1 | 39822625001 | 1 VIAL in 1 CARTON (39822-6250-1) / 10 mL in 1 VIALMarketed from Mar 22, 2024 |
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)
- Desmopressin Acetate
- Generic name (nonproprietary)
- desmopressin acetate
- Active ingredients
- Desmopressin acetate — 4 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210223
- Marketing start
- Listing expires
- Other FDA classes
- Increased Coagulation Factor VIII Activity (Physiologic effect)Increased Coagulation Factor VIII Concentration (Physiologic effect)Vasopressins (Chemical structure)
- Identifiers
- Product ID 39822-6250_0ec4ffe1-0ee2-fc69-e063-6394a90ab7fbSPL ID 0ec4ffe1-0ee2-fc69-e063-6394a90ab7fbSPL set ID 1052a869-b64d-655d-e063-6294a90ad0e2RxCUI 849501, 1723232UNII XB13HYU18UUPC 0339822625017, 0339822620012
- Pharmacologic class
- Factor VIII Activator; Vasopressin Analog
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
N439822625001followed by a unit qualifier and the quantityPackage 39822-6250-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Desmopressin acetate injection is a vasopressin analog used for: Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. ( 1.1 ) Hemophilia A - for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. ( 1.2 ) von Willebrand's disease (Type I) - for patients with mild to moderate disease …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210223
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 |
|---|---|---|---|---|
| Desmopressin Acetate | Desmopressin acetate 40 ug/10mL | InjectionIntravenous, Subcutaneous | UBI Pharma Inc. | 72843-440 |
| Desmopressin Acetate | Desmopressin acetate 4 ug/mL | InjectionIntravenous, Subcutaneous | UBI Pharma Inc. | 72843-461 |
| Desmopressin Acetate | Desmopressin acetate 4 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Avenacy, Inc. | 83634-451 |
| Desmopressin Acetate | Desmopressin acetate 4 ug/mL | Injection, SolutionIntravenous, Subcutaneous | The J. Molner Company LLC | 83148-126 |
| Desmopressin Acetate | Desmopressin acetate 4 ug/mL | Injection, SolutionIntravenous, Subcutaneous | XGen Pharmaceuticals DJB, Inc. | 39822-6200 |