NDC 61919-305

CYCLOBENZAPRINE

Cyclobenzaprine

CYCLOBENZAPRINE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Cyclobenzaprine.

Product ID61919-305_43cc254b-6634-63dd-e054-00144ff88e88
NDC61919-305
Product TypeHuman Prescription Drug
Proprietary NameCYCLOBENZAPRINE
Generic NameCyclobenzaprine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-12-16
Marketing CategoryANDA / ANDA
Application NumberANDA090478
Labeler NameDIRECT RX
Substance NameCYCLOBENZAPRINE
Active Ingredient Strength5 mg/1
Pharm ClassesCentrally-media
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-305-30

30 TABLET, FILM COATED in 1 BOTTLE (61919-305-30)
Marketing Start Date2016-12-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-305-30 [61919030530]

CYCLOBENZAPRINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-16

NDC 61919-305-60 [61919030560]

CYCLOBENZAPRINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-16

NDC 61919-305-90 [61919030590]

CYCLOBENZAPRINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-16

Drug Details

Pharmacological Class

  • Centrally-mediated Muscle Relaxation [PE]
  • Muscle Relaxant [EPC]

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

NDCBrand NameGeneric Name
53149-4842CyclobenzaprineCyclobenzaprine Hydrochloride
57237-266CyclobenzaprineCyclobenzaprine Hydrochloride
61919-305CYCLOBENZAPRINECYCLOBENZAPRINE
0615-8084Cyclobenzaprine HydrochlorideCyclobenzaprine
50090-3253Cyclobenzaprine HydrochlorideCyclobenzaprine
50268-191Cyclobenzaprine HydrochlorideCyclobenzaprine
50436-0846Cyclobenzaprine HydrochlorideCyclobenzaprine
51655-973Cyclobenzaprine HydrochlorideCyclobenzaprine
53002-0521Cyclobenzaprine HydrochlorideCyclobenzaprine
53002-3080Cyclobenzaprine HydrochlorideCyclobenzaprine
55700-459Cyclobenzaprine HydrochlorideCyclobenzaprine
58118-0846Cyclobenzaprine HydrochlorideCyclobenzaprine
60687-558Cyclobenzaprine HydrochlorideCyclobenzaprine
63187-812Cyclobenzaprine HydrochlorideCyclobenzaprine
67046-148Cyclobenzaprine HydrochlorideCyclobenzaprine
67296-1728Cyclobenzaprine HydrochlorideCyclobenzaprine
68071-3149Cyclobenzaprine HydrochlorideCyclobenzaprine
68071-3150Cyclobenzaprine HydrochlorideCyclobenzaprine
68071-3154Cyclobenzaprine HydrochlorideCyclobenzaprine
68645-517Cyclobenzaprine HydrochlorideCyclobenzaprine
68645-518Cyclobenzaprine HydrochlorideCyclobenzaprine
68788-7398Cyclobenzaprine HydrochlorideCyclobenzaprine
69097-845Cyclobenzaprine HydrochlorideCyclobenzaprine
69097-846Cyclobenzaprine HydrochlorideCyclobenzaprine
70518-0082Cyclobenzaprine HydrochlorideCyclobenzaprine
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