Methocarbamol and Aspirin
Methocarbamol and Aspirin TabletsRx onlyJerome Stevens Pharmaceuticals, Inc.
Approved
Approval ID
055edd83-bab7-486a-a2b8-dad9f3bae916
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2021
Manufacturers
FDA
Jerome Stevens Pharmaceuticals, Inc.
DUNS: 021130638
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methocarbamol and Aspirin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50564-490
Application NumberANDA081145
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methocarbamol and Aspirin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2021
FDA Product Classification
INGREDIENTS (10)
methocarbamolActive
Quantity: 400 mg in 1 1
Code: 125OD7737X
Classification: ACTIB
povidoneInactive
Code: FZ989GH94E
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
aspirinActive
Quantity: 325 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT