Methocarbamol
Methocarbamol Tablets Rx Only
Approved
Approval ID
7dafab15-db4c-4425-b1a2-e56433ecccf6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 7, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methocarbamol Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43063-903
Application NumberANDA209312
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methocarbamol Tablets
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2023
FDA Product Classification
INGREDIENTS (13)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
METHOCARBAMOLActive
Quantity: 500 mg in 1 1
Code: 125OD7737X
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT