Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Direct_Rx
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Direct_Rx
Direct_Rx
Direct_Rx
079254320
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METHOCARBAMOL
Product Details
NDC Product Code
61919-903Application Number
ANDA090200Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 6, 2023STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
MethocarbamolActive
Code: 125OD7737XClass: ACTIBQuantity: 750 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT