Amitiza

Product NDC: 63629-6398
11-digit product format: 636296398
Labeler code: 63629
Product ID: 63629-6398_7c16f8c0-d82c-4242-905c-a97837ce03b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lubiprostone
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA021908
Marketing category: NDA
Marketing start: 2006-01-31
Marketing end: 0000-00-00
Substance: LUBIPROSTONE
Active strength: 24 ug/1
Pharmacologic classes: Chloride Channel Activator [EPC],Chloride Channel Activators [MoA]
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
63629-6398-1	2020-10-16	C162847	48780-1	9d75b9d0-8191-f424-e053-dadaa90a57ce	70b0fe82-92b9-4aee-8aa5-e1e0af003b71
63629-6398-1	2020-01-31	C162847	48780-1	9d75b9d0-8191-f424-e053-dadaa90a57ce	70b0fe82-92b9-4aee-8aa5-e1e0af003b71

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7662KG2R6K	LUBIPROSTONE	136790-76-6	LUBIPROSTONE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-6398-1	63629639801	90 CAPSULE, GELATIN COATED in 1 BOTTLE (63629-6398-1)	2015-09-04	0000-00-00	No	No	Current