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
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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-295-10 | Desmopressin Acetate | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 1 |
| 65219-295-10 | Desmopressin Acetate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-295 | DESMOPRESSIN ACETATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, 2 package rows | 20230912_9725ba8e-ac0f-4655-bb98-9ea926142815.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |