Prescription drug · ANDA
Desmopressin Acetate NDC 68682-342
Desmopressin acetate .1 mg/mL · Solution · Nasal · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-342-05 | 68682034205 | 1 BOTTLE, PUMP in 1 CARTON (68682-342-05) / 5 mL in 1 BOTTLE, PUMPMarketed from Jun 1, 2025 |
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)
- Desmopressin Acetate
- Generic name (nonproprietary)
- desmopressin acetate
- Active ingredients
- Desmopressin acetate — .1 mg/mL
- Dosage form
- Solution
- Route
- Nasal
- Labeler
- Oceanside Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074830
- Marketing start
- Marketing end
- Other FDA classes
- Increased Coagulation Factor VIII Activity (Physiologic effect)Increased Coagulation Factor VIII Concentration (Physiologic effect)Vasopressins (Chemical structure)
- Identifiers
- Product ID 68682-342_97c5146c-9da2-408d-859c-c35abbd82893SPL ID 97c5146c-9da2-408d-859c-c35abbd82893SPL set ID 8034989a-45f5-436b-8b1f-42108ee2a21aRxCUI 849506UNII XB13HYU18U
- 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 HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468682034205followed by a unit qualifier and the quantityPackage 68682-0342-05. 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)
Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older. Limitations of Use: Desmopressin nasal spray solution is not indicated for: • Treatment of nephrogenic diabetes insipidus, • Treatment of primary nocturnal enuresis [ see Warnings and Precautions (5.1) ], • Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2) ], • Use in patients with …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074830
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 .1 mg/mL | SolutionNasal | Bauch & Lomb Incorporated | 24208-342 |