NDC 72189-101

CYCLOBENZAPRINE HYDROCHLORIDE

Cyclobenzaprine Hydrochloride

CYCLOBENZAPRINE HYDROCHLORIDE is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Cyclobenzaprine Hydrochloride.

Product ID72189-101_a512d34c-8165-0c04-e053-2995a90a1942
NDC72189-101
Product TypeHuman Prescription Drug
Proprietary NameCYCLOBENZAPRINE HYDROCHLORIDE
Generic NameCyclobenzaprine Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-05-07
Marketing CategoryANDA / ANDA
Application NumberANDA091281
Labeler NameDIRECT RX
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength15 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 72189-101-60

60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-101-60)
Marketing Start Date2020-05-07
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE15 mg/1

NDC Crossover Matching brand name "CYCLOBENZAPRINE HYDROCHLORIDE" or generic name "Cyclobenzaprine Hydrochloride"

NDCBrand NameGeneric Name
0093-1920Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0093-1921Cyclobenzaprine 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
0615-8084Cyclobenzaprine HydrochlorideCyclobenzaprine
0615-8182Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
0904-7809Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
10544-072Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
10544-159Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
10544-200Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
10702-006Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
10702-007Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
12634-528Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
21695-036Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
21695-037Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
24979-035Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
24979-036Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
31722-282Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
31722-283Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
33261-033Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
33261-377Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
33261-859CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE
33358-097Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
42708-081Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
42708-106Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
43063-494Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
43063-516Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
43063-917Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
43547-399Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
43547-400Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
45865-433Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
45865-685Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
45865-801Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
50090-0375Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
50090-0377Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
50090-0378Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
50090-0969Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
50090-1848Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.