Desmopressin Acetate
- Product NDC
- 65145-184
- 11-digit product format
- 651450184
- Labeler code
- 65145
- Product ID
- 65145-184_84dbb392-4535-4cbc-af60-75abb494f26e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Desmopressin Acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Caplin Steriles Limited
- Application
- ANDA219981
- Marketing category
- ANDA
- Marketing start
- 2026-03-16
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Desmopressin Acetate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DESMOPRESSIN ACETATE | 4 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XB13HYU18U |
| Rxcui | 849501, 1723232 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65145-184-01 | Desmopressin Acetate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
| 65145-184-01 | Desmopressin Acetate | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 65145-184-01 | 65145018401 | 1 VIAL, MULTI-DOSE in 1 CARTON (65145-184-01) / 10 mL in 1 VIAL, MULTI-DOSE | 2026-03-16 | No | No | Historical |