NDC 80425-0015

Flexeril

Cyclobenzaprine Hydrochloride

Flexeril is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Advanced Rx Pharmacy Of Tennessee, Llc. The primary component is Cyclobenzaprine Hydrochloride.

Product ID80425-0015_b2c11392-8868-0b8d-e053-2a95a90afc73
NDC80425-0015
Product TypeHuman Prescription Drug
Proprietary NameFlexeril
Generic NameCyclobenzaprine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-01-16
Marketing CategoryANDA / ANDA
Application NumberANDA078722
Labeler NameADVANCED RX PHARMACY OF TENNESSEE, LLC
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 80425-0015-3

90 TABLET, FILM COATED in 1 BOTTLE (80425-0015-3)
Marketing Start Date2018-01-16
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Flexeril" or generic name "Cyclobenzaprine Hydrochloride"

NDCBrand NameGeneric Name
80425-0019FlexerilFlexeril
80425-0018FlexerilFlexeril
80425-0017FlexerilFlexeril
80425-0078FlexerilFlexeril
80425-0015FlexerilFlexeril
80425-0016FlexerilFlexeril
0093-1920Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0093-1921Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0093-3420Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0093-3421Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0093-3422Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0115-1436Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0115-1437Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0179-0057cyclobenzaprine hydrochloridecyclobenzaprine hydrochloride
0179-0189cyclobenzaprine hydrochloridecyclobenzaprine hydrochloride
0378-0751Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
0378-0761Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
0378-0771Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
0440-1350Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0440-7350Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0591-3256Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0591-3330Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0591-5658Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0615-3520Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
0615-7528Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
0615-8182Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0904-7809Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride

Trademark Results [Flexeril]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLEXERIL
FLEXERIL
98022112 not registered Live/Pending
Hi-Tech Pharmaceuticals, Inc.
2023-05-31
FLEXERIL
FLEXERIL
73111611 1077237 Live/Registered
MERCK & CO., INC.
1977-01-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.