Desmopressin Acetate
- Product NDC
- 68462-276
- 11-digit product format
- 684620276
- Labeler code
- 68462
- Product ID
- 68462-276_d9414e03-41d5-4e96-9ce6-b298c365281d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Desmopressin Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc.,USA
- Application
- ANDA201831
- Marketing category
- ANDA
- Marketing start
- 2015-05-28
- Substance
- DESMOPRESSIN ACETATE
- Active strength
- .2 mg/1
- 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 | .2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XB13HYU18U |
| Rxcui | 833008, 849515 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-276-01 | Desmopressin Acetate | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 68462-276-10 | Desmopressin Acetate | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
| 68462-276-30 | Desmopressin Acetate | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 68462-276-90 | Desmopressin Acetate | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DESMOPRESSIN ACETATE | ACTIVE INGREDIENT | XB13HYU18U | DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA] | 2 | |
| DESMOPRESSIN | ACTIVE MOIETY | ENR1LLB0FP | DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA] | 2 | |
| STARCH, POTATO | INACTIVE INGREDIENT | 8I089SAH3T | DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-276 | DESMOPRESSIN ACETATE TABLET [GLENMARK PHARMACEUTICALS INC.,USA] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240104_7a26b415-77cd-4b2f-9c76-fa52d2eb6be6.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 |
|---|
| 68462-276-01 | 68462027601 | 100 TABLET in 1 BOTTLE (68462-276-01) | 100 tablet | 2015-05-28 | 0000-00-00 | No | No | Current |
| 68462-276-10 | 68462027610 | 1000 TABLET in 1 BOTTLE (68462-276-10) | 1000 tablet | 2015-05-28 | 0000-00-00 | No | No | Current |
| 68462-276-30 | 68462027630 | 30 TABLET in 1 BOTTLE (68462-276-30) | 30 tablet | 2015-05-28 | 0000-00-00 | No | No | Current |
| 68462-276-90 | 68462027690 | 90 TABLET in 1 BOTTLE (68462-276-90) | 90 tablet | 2015-05-28 | 0000-00-00 | No | No | Current |