PredniSONE

Product NDC: 50090-6621
11-digit product format: 500906621
Labeler code: 50090
Product ID: 50090-6621_ba761d3b-668e-4b97-87c8-d971cb80419c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PredniSONE
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA080352
Marketing category: ANDA
Marketing start: 2020-03-23
Substance: PREDNISONE
Active strength: 5 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 50090-6621_ba761d3b-668e-4b97-87c8-d971cb80419c
SPL ID: ba761d3b-668e-4b97-87c8-d971cb80419c
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: PredniSONE
Generic name: PredniSONE
Dosage form: TABLET
Route: ORAL
Marketing start: 2020-03-23
Marketing category: ANDA
Application number: ANDA080352
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA]; Corticosteroid [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
PREDNISONE	5 mg/1

Package NDC	Description	Marketing start	Sample
50090-6621-6	90 TABLET in 1 BOTTLE (50090-6621-6)	2023-08-24	No

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

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-6621-6	50090662106	90 TABLET in 1 BOTTLE (50090-6621-6)	90 tablet	2023-08-24	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP	A-S Medication Solutions	2023-08-31	HUMAN PRESCRIPTION DRUG LABEL	1