Desmopressin Acetate
- Product NDC
- 83634-451
- 11-digit product format
- 836340451
- Labeler code
- 83634
- Product ID
- 83634-451_0181c37e-c05d-47c4-bf3d-126c84bbf063
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- desmopressin acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Avenacy, Inc.
- Application
- ANDA210223
- Marketing category
- ANDA
- Marketing start
- 2024-01-15
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Desmopressin Acetate
- Listing expiration
- 2026-12-31
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 |
|---|
| 83634-451-01 | Desmopressin Acetate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
| 83634-451-10 | Desmopressin Acetate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
| 83634-451-10 | Desmopressin Acetate | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 1 |
| 83634-451-41 | Desmopressin Acetate | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83634-451 | DESMOPRESSIN ACETATE INJECTION, SOLUTION [AVENACY, INC.] | 1 | Current NDC, 4 package rows | 20240115_c2e21331-4d54-4fa7-8f0d-31fe23a981aa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83634-451-01 | 83634045101 | 10 VIAL in 1 CARTON (83634-451-01) / 1 mL in 1 VIAL (83634-451-41) | 10 vial | 2024-01-15 | No | No | Current |
| 83634-451-10 | 83634045110 | 1 VIAL in 1 CARTON (83634-451-10) / 10 mL in 1 VIAL | 1 vial | 2024-01-15 | No | No | Current |
| 83634-451-41 | 83634045141 | 1 mL in 1 VIAL | 1 ml | | | | Historical |