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NDC 54436-0350-30 NOCDURNA 55.3 ug/1 Details
NOCDURNA 55.3 ug/1
NOCDURNA is a SUBLINGUAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Antares Pharma, Inc.. The primary component is DESMOPRESSIN ACETATE.
MedlinePlus Drug Summary
Desmopressin is used to control the symptoms of a certain type of diabetes insipidus ('water diabetes'; condition in which the body produces an abnormally large amount of urine). Desmopressin is also used to control excessive thirst and the passage of an abnormally large amount of urine that may occur after a head injury or after certain types of surgery. Desmopressin is also used to control bed-wetting. Desmopressin is in a class of medications called hormones. It works by replacing vasopressin, a hormone that is normally produced in the body to help balance the amount of water and salt.
Related Packages: 54436-0350-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Desmopressin
Product Information
| NDC | 54436-0350 |
|---|---|
| Product ID | 54436-350_bba94cdc-188c-45ff-9423-b2c971bcc13c |
| Associated GPIs | 30201010100715 |
| GCN Sequence Number | 073153 |
| GCN Sequence Number Description | desmopressin acetate TAB RAPDIS 55.3 MCG SUBLINGUAL |
| HIC3 | P2B |
| HIC3 Description | ANTIDIURETIC AND VASOPRESSOR HORMONES |
| GCN | 37509 |
| HICL Sequence Number | 002841 |
| HICL Sequence Number Description | DESMOPRESSIN ACETATE |
| Brand/Generic | Brand |
| Proprietary Name | NOCDURNA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DESMOPRESSIN ACETATE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | SUBLINGUAL |
| Active Ingredient Strength | 55.3 |
| Active Ingredient Units | ug/1 |
| Substance Name | DESMOPRESSIN ACETATE |
| Labeler Name | Antares Pharma, Inc. |
| Pharmaceutical Class | Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022517 |
| Listing Certified Through | n/a |
Package
NDC 54436-0350-30 (54436035030)
| NDC Package Code | 54436-350-30 |
|---|---|
| Billing NDC | 54436035030 |
| Package | 3 BLISTER PACK in 1 CARTON (54436-350-30) / 10 TABLET in 1 BLISTER PACK (54436-350-10) |
| Marketing Start Date | 2021-08-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |