Desmopressin Acetate

Product NDC: 70518-3149
11-digit product format: 705183149
Labeler code: 70518
Product ID: 70518-3149_c71926d8-0067-565d-e053-2995a90a46cd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: desmopressin acetate
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077414
Marketing category: ANDA
Marketing start: 2021-07-13
Marketing end: 0000-00-00
Substance: DESMOPRESSIN ACETATE
Active strength: 0 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: 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
70518-3149-0	2023-03-17	C162847	48780-1	f386c64a-0583-0266-e053-dadaa90a7c1a	95c49692-0a71-42c4-b370-b7cd8484cefe
70518-3149-0	2023-01-30	C162847	48780-1	f386c64a-0583-0266-e053-dadaa90a7c1a	95c49692-0a71-42c4-b370-b7cd8484cefe

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3149	DESMOPRESSIN ACETATE TABLET [REMEDYREPACK INC.]	2	Legacy NDC	20230318_95c49692-0a71-42c4-b370-b7cd8484cefe.zip

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
70518-3149-0	70518314900	100 POUCH in 1 BOX (70518-3149-0) > 1 TABLET in 1 POUCH (70518-3149-1)	100 pouch	2021-07-13	0000-00-00	No	No	Current