Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
St Mary's Medical Park Pharmacy
St Mary's Medical Park Pharmacy
063050751
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cyclobenzaprine Hydrochloride
Product Details
NDC Product Code
60760-536Application Number
ANDA078643Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 15, 2023STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CyclobenzaprineActive
Code: 0VE05JYS2PClass: ACTIBQuantity: 5 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT