NOCDURNA
- Product NDC
- 54436-325
- 11-digit product format
- 544360325
- Labeler code
- 54436
- Product ID
- 54436-325_24aa2c46-f63b-49c2-932e-8b9cbadd415a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DESMOPRESSIN ACETATE
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Antares Pharma, Inc.
- Application
- NDA022517
- Marketing category
- NDA
- Marketing start
- 2021-08-06
- Marketing end
- 0000-00-00
- Substance
- DESMOPRESSIN ACETATE
- Active strength
- 28 ug/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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54436-325 | NOCDURNA (DESMOPRESSIN ACETATE) TABLET [ANTARES PHARMA, INC.] | 3 | Legacy NDC | 20231021_cf51914a-55df-4b4a-8ea8-c7af257c1d59.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54436-325-30 | 54436032530 | 3 BLISTER PACK in 1 CARTON (54436-325-30) > 10 TABLET in 1 BLISTER PACK (54436-325-10) | 3 blister pack | 2021-08-06 | 0000-00-00 | No | No | Current |