Jentadueto

Product NDC: 63629-6524
11-digit product format: 636296524
Labeler code: 63629
Product ID: 63629-6524_b81bd234-7dcb-4bf5-8396-38f8a39d0ea1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: linagliptin and metformin hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA201281
Marketing category: NDA
Marketing start: 2012-02-13
Marketing end: 0000-00-00
Substance: LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Active strength: 3 mg/1; g/1
Pharmacologic classes: Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-6524-1	2021-06-11	C162847	48780-1	9d75b9d0-2923-f424-e053-dadaa90a57ce	3010d452-dab5-44c5-b8d0-bdc725679f07
63629-6524-1	2020-01-31	C162847	48780-1	9d75b9d0-2923-f424-e053-dadaa90a57ce	3010d452-dab5-44c5-b8d0-bdc725679f07

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X29ZEJ4R2	LINAGLIPTIN	668270-12-0	LINAGLIPTIN
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-6524-1	63629652401	60 TABLET, FILM COATED in 1 BOTTLE (63629-6524-1)	2015-07-27	0000-00-00	No	No	Current