Desmopressin Acetate
- Product NDC
- 68083-550
- 11-digit product format
- 680830550
- Labeler code
- 68083
- Product ID
- 68083-550_0f297b51-3d85-43b9-b96b-88a82858fe3c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Desmopressin Acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA216922
- Marketing category
- ANDA
- Marketing start
- 2022-11-16
- Substance
- DESMOPRESSIN ACETATE
- Active strength
- 4 ug/mL
- Pharmacologic classes
- Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| XB13HYU18U | DESMOPRESSIN ACETATE | 62357-86-2 | DESMOPRESSIN ACETATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-550-10 | 68083055010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-550-10) / 1 mL in 1 VIAL, SINGLE-DOSE (68083-550-01) | 2022-11-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Desmopressin Acetate | Gland Pharma Limited | 2022-11-18 | Human Prescription Drug Label | 5 |