PredniSONE

Product NDC: 63629-7388
11-digit product format: 636297388
Labeler code: 63629
Product ID: 63629-7388_017b9466-57f2-41e2-863b-75c67957cf57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PredniSONE
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA084122
Marketing category: ANDA
Marketing start: 2003-02-13
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 10 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [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
63629-7388-1	2020-10-12	C162847	48780-1	9d75b9d0-e44f-f424-e053-dadaa90a57ce	2ff467a4-1e1f-4103-8cf8-7a81d3170c16
63629-7388-1	2020-01-31	C162847	48780-1	9d75b9d0-e44f-f424-e053-dadaa90a57ce	2ff467a4-1e1f-4103-8cf8-7a81d3170c16

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VB0R961HZT	PREDNISONE	53-03-2	PREDNISONE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-7388-1	63629738801	20 TABLET in 1 BOTTLE (63629-7388-1)	20 tablet	2017-09-12	0000-00-00	No	No	Current