NDC 61919-681

CYCLOBENZAPRINE HCI

Cyclobenzaprine Hci

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

Product ID61919-681_85b93754-7c21-26d6-e053-2991aa0a724a
NDC61919-681
Product TypeHuman Prescription Drug
Proprietary NameCYCLOBENZAPRINE HCI
Generic NameCyclobenzaprine Hci
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-02
Marketing CategoryANDA / ANDA
Application NumberANDA078722
Labeler NameDIRECTRX
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-681-90

90 TABLET, FILM COATED in 1 BOTTLE (61919-681-90)
Marketing Start Date2019-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-681-90 [61919068190]

CYCLOBENZAPRINE HCI TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078722
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-02

Drug Details

Pharmacological Class

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

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