Desmopressin Acetate

Product NDC: 70518-3125
11-digit product format: 705183125
Labeler code: 70518
Product ID: 70518-3125_c4fa77a8-d454-9856-e053-2a95a90ae192
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desmopressin Acetate
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA201831
Marketing category: ANDA
Marketing start: 2021-06-17
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
70518-3125-0	2023-03-17	C162847	48780-1	f386c64a-4115-0266-e053-dadaa90a7c1a	af65b08b-4c20-4b47-86d4-78c8f767f9f8
70518-3125-0	2023-01-30	C162847	48780-1	f386c64a-4115-0266-e053-dadaa90a7c1a	af65b08b-4c20-4b47-86d4-78c8f767f9f8

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
70518-3125-0	70518312500	100 POUCH in 1 BOX (70518-3125-0) > 1 TABLET in 1 POUCH (70518-3125-1)	100 pouch	2021-06-17	0000-00-00	No	No	Current