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 72789-036
Product ID 72789-036_34032d5b-b9ee-6ece-e063-6294a90a36ee
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 72789036
Hyphenated Format 72789-036

Supplemental Identifiers

RxCUI
828348
UPC
0372789036908
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
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-01)
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-15)
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-21)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-60)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-82)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-90)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-93)
  • 270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-94)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-95)
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-98)
source: ndc

Packages (12)

72789-036-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-01) 72789-036-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-15) 72789-036-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-21) 72789-036-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-30) 72789-036-45 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-45) 72789-036-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-60) 72789-036-82 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-82) 72789-036-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-90) 72789-036-93 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-93) 72789-036-94 270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-94) 72789-036-95 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-95) 72789-036-98 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-98)

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": "34032d5b-b9ee-6ece-e063-6294a90a36ee", "openfda": {"upc": ["0372789036908"], "unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["3aaa4808-7f2d-410c-9b6c-193549ec0845"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-01)", "package_ndc": "72789-036-01", "marketing_start_date": "20191213"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-15)", "package_ndc": "72789-036-15", "marketing_start_date": "20170330"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-21)", "package_ndc": "72789-036-21", "marketing_start_date": "20170330"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-30)", "package_ndc": "72789-036-30", "marketing_start_date": "20200225"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-45)", "package_ndc": "72789-036-45", "marketing_start_date": "20200225"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-60)", "package_ndc": "72789-036-60", "marketing_start_date": "20200225"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-82)", "package_ndc": "72789-036-82", "marketing_start_date": "20191213"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-90)", "package_ndc": "72789-036-90", "marketing_start_date": "20200225"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-93)", "package_ndc": "72789-036-93", "marketing_start_date": "20200225"}, {"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-94)", "package_ndc": "72789-036-94", "marketing_start_date": "20200225"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-95)", "package_ndc": "72789-036-95", "marketing_start_date": "20191213"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-98)", "package_ndc": "72789-036-98", "marketing_start_date": "20200225"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "72789-036_34032d5b-b9ee-6ece-e063-6294a90a36ee", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "72789-036", "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"}