methylprednisolone

Product NDC: 82804-007
11-digit product format: 828040007
Labeler code: 82804
Product ID: 82804-007_177fd649-4339-4bfd-bd12-7e8de302412b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylprednisolone
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA206751
Marketing category: ANDA
Marketing start: 2018-05-01
Substance: METHYLPREDNISOLONE
Active strength: 4 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: 82804-007_177fd649-4339-4bfd-bd12-7e8de302412b
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: methylprednisolone
Generic name: methylprednisolone
Dosage form: TABLET
Route: ORAL
Marketing start: 2018-05-01
Marketing category: ANDA
Application number: ANDA206751
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA]; Corticosteroid [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
METHYLPREDNISOLONE	4 mg/1

UNII	Preferred term	Registry number	Matched term
X4W7ZR7023	METHYLPREDNISOLONE	83-43-2	METHYLPREDNISOLONE

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-007-21	82804000721	21 TABLET in 1 BOTTLE (82804-007-21)	21 tablet	2023-09-08	No	No	Current
82804-007-30	82804000730	30 TABLET in 1 BOTTLE (82804-007-30)	30 tablet	2023-09-08	No	No	Current
82804-007-60	82804000760	60 TABLET in 1 BOTTLE (82804-007-60)	60 tablet	2023-09-08	No	No	Current
82804-007-90	82804000790	90 TABLET in 1 BOTTLE (82804-007-90)	90 tablet	2023-09-08	No	No	Current

Title	Manufacturer	Effective date	Type	Version
METHYLPREDNISOLONE TABLETS, USP	Proficient Rx LP	2023-09-01	HUMAN PRESCRIPTION DRUG LABEL	1