Desmopressin Acetate
- Product NDC
- 65219-295
- 11-digit product format
- 652190295
- Labeler code
- 65219
- Product ID
- 65219-295_499d7fa7-43ab-47f0-ae4b-0f9791745f14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Desmopressin Acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA216904
- Marketing category
- ANDA
- Marketing start
- 2023-09-11
- 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 |
|---|
| 65219-295-10 | 65219029510 | 1 VIAL, MULTI-DOSE in 1 CARTON (65219-295-10) / 10 mL in 1 VIAL, MULTI-DOSE | 2023-09-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Desmopressin Acetate | Fresenius Kabi USA, LLC | Gland Pharma Limited | 2023-09-06 | HUMAN PRESCRIPTION DRUG LABEL | 1 |