Desmopressin Acetate
- Product NDC
- 43598-053
- 11-digit product format
- 435980053
- Labeler code
- 43598
- Product ID
- 43598-053_58e7affd-0fce-80fb-be3b-7f438f332011
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Desmopressin Acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA215961
- Marketing category
- ANDA
- Marketing start
- 2022-09-12
- 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 |
|---|
| 43598-053-11 | Desmopressin Acetate | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 3 |
| 43598-053-11 | Desmopressin Acetate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-053 | DESMOPRESSIN ACETATE INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220912_60dd8694-58d8-d88e-26f2-f28baa53787e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-053-11 | 43598005311 | 1 VIAL in 1 CARTON (43598-053-11) / 10 mL in 1 VIAL | 1 vial | 2022-09-12 | 0000-00-00 | No | No | Current |