NOCDURNA

Product NDC: 55566-5050
11-digit product format: 555665050
Labeler code: 55566
Product ID: 55566-5050_763a3d42-80dc-491a-b67d-7098d8cafb0b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DESMOPRESSIN ACETATE
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Ferring Pharmaceuticals Inc.
Application: NDA022517
Marketing category: NDA
Marketing start: 2018-10-22
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: 2022-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55566-5050-1	2023-01-31	C162847	48780-1	f386c649-fabf-0266-e053-dadaa90a7c1a	8ef937d4-0bb5-46bd-9b53-9b14b9d2738f

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55566-5050-1	EA - Each	55566-5050	b6e4da7d-b9a0-4426-8d0d-701cc9776cae	1	2018-11-06

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XB13HYU18U	DESMOPRESSIN ACETATE	62357-86-2	DESMOPRESSIN ACETATE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55566-5050-1	55566505001	3 BLISTER PACK in 1 CARTON (55566-5050-1) > 10 TABLET in 1 BLISTER PACK (55566-5050-0)	3 blister pack	2018-10-22	2022-07-31	No	No	Current