Amlodipine Besylate

Product NDC: 63629-6631
11-digit product format: 636296631
Labeler code: 63629
Product ID: 63629-6631_531ae69a-64a7-4856-82e8-5ae1bf966ef6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine Besylate
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077955
Marketing category: ANDA
Marketing start: 2011-01-01
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE
Active strength: 10 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [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
63629-6631-1	2020-10-16	C162847	48780-1	9d75b9cf-d379-f424-e053-dadaa90a57ce	33df914e-9251-4c00-81f3-d6ae3874664f
63629-6631-1	2020-01-31	C162847	48780-1	9d75b9cf-d379-f424-e053-dadaa90a57ce	33df914e-9251-4c00-81f3-d6ae3874664f

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-6631-1	63629663101	30 TABLET in 1 BOTTLE (63629-6631-1)	30 tablet	2015-08-10	0000-00-00	No	No	Current