cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-494
Product ID 43063-494_4138b440-6586-92bc-e063-6394a90a3a3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078048
Listing Expiration 2026-12-31
Marketing Start 2014-07-31

Pharmacologic Class

Classes
centrally-mediated muscle relaxation [pe] muscle relaxant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063494
Hyphenated Format 43063-494

Supplemental Identifiers

RxCUI
828320
UPC
0343063494219
UNII
0VE05JYS2P

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cyclobenzaprine hydrochloride (source: ndc)
Generic Name cyclobenzaprine hydrochloride (source: ndc)
Application Number ANDA078048 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-01)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-14)
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-20)
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-21)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-60)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-82)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-95)
source: ndc

Packages (11)

43063-494-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-01) 43063-494-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-10) 43063-494-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-14) 43063-494-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-15) 43063-494-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-20) 43063-494-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-21) 43063-494-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-30) 43063-494-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-60) 43063-494-82 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-82) 43063-494-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-90) 43063-494-95 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-95)

Ingredients (1)

cyclobenzaprine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Cyclobenzaprine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
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