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 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-046
Product ID 72789-046_3403a5e2-c822-d823-e063-6394a90a7142
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077797
Listing Expiration 2026-12-31
Marketing Start 2017-03-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789046
Hyphenated Format 72789-046

Supplemental Identifiers

RxCUI
828348
UPC
0372789046303
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 ANDA077797 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-03)
  • 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-04)
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-06)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-10)
  • 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-12)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-14)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-30)
  • 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-40)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-60)
source: ndc

Packages (10)

72789-046-03 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-03) 72789-046-04 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-04) 72789-046-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-06) 72789-046-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-10) 72789-046-12 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-12) 72789-046-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-14) 72789-046-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-20) 72789-046-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-30) 72789-046-40 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-40) 72789-046-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-60)

Ingredients (1)

cyclobenzaprine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cyclobenzaprine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3403a5e2-c822-d823-e063-6394a90a7142", "openfda": {"upc": ["0372789046303"], "unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["7829a96a-3668-4d88-90e9-0ecbedb2bd7e"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-03)", "package_ndc": "72789-046-03", "marketing_start_date": "20200107"}, {"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-04)", "package_ndc": "72789-046-04", "marketing_start_date": "20200106"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-06)", "package_ndc": "72789-046-06", "marketing_start_date": "20200717"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-10)", "package_ndc": "72789-046-10", "marketing_start_date": "20200108"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-12)", "package_ndc": "72789-046-12", "marketing_start_date": "20200615"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-14)", "package_ndc": "72789-046-14", "marketing_start_date": "20200127"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-20)", "package_ndc": "72789-046-20", "marketing_start_date": "20200106"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-30)", "package_ndc": "72789-046-30", "marketing_start_date": "20200106"}, {"sample": false, "description": "40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-40)", "package_ndc": "72789-046-40", "marketing_start_date": "20200601"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-60)", "package_ndc": "72789-046-60", "marketing_start_date": "20200106"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "72789-046_3403a5e2-c822-d823-e063-6394a90a7142", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "72789-046", "generic_name": "cyclobenzaprine hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA077797", "marketing_category": "ANDA", "marketing_start_date": "20170330", "listing_expiration_date": "20261231"}