cyclobenzaprine hydrochloride

Generic: cyclobenzaprine

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-812
Product ID 63187-812_3afe19fb-b693-47f7-a08e-a46cc756ffda
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090478
Listing Expiration 2026-12-31
Marketing Start 2016-07-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187812
Hyphenated Format 63187-812

Supplemental Identifiers

RxCUI
828348
UPC
0363187812720
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 (source: ndc)
Application Number ANDA090478 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 7 TABLET, FILM COATED in 1 BOTTLE (63187-812-07)
  • 10 TABLET, FILM COATED in 1 BOTTLE (63187-812-10)
  • 12 TABLET, FILM COATED in 1 BOTTLE (63187-812-12)
  • 15 TABLET, FILM COATED in 1 BOTTLE (63187-812-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (63187-812-20)
  • 21 TABLET, FILM COATED in 1 BOTTLE (63187-812-21)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-812-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (63187-812-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-812-60)
  • 120 TABLET, FILM COATED in 1 BOTTLE (63187-812-72)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63187-812-90)
source: ndc

Packages (11)

63187-812-07 7 TABLET, FILM COATED in 1 BOTTLE (63187-812-07) 63187-812-10 10 TABLET, FILM COATED in 1 BOTTLE (63187-812-10) 63187-812-12 12 TABLET, FILM COATED in 1 BOTTLE (63187-812-12) 63187-812-15 15 TABLET, FILM COATED in 1 BOTTLE (63187-812-15) 63187-812-20 20 TABLET, FILM COATED in 1 BOTTLE (63187-812-20) 63187-812-21 21 TABLET, FILM COATED in 1 BOTTLE (63187-812-21) 63187-812-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-812-30) 63187-812-45 45 TABLET, FILM COATED in 1 BOTTLE (63187-812-45) 63187-812-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-812-60) 63187-812-72 120 TABLET, FILM COATED in 1 BOTTLE (63187-812-72) 63187-812-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-812-90)

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": "3afe19fb-b693-47f7-a08e-a46cc756ffda", "openfda": {"upc": ["0363187812720"], "unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["ae6de8d8-33c2-40bd-9dd3-782c879a9d8f"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (63187-812-07)", "package_ndc": "63187-812-07", "marketing_start_date": "20210514"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (63187-812-10)", "package_ndc": "63187-812-10", "marketing_start_date": "20170801"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (63187-812-12)", "package_ndc": "63187-812-12", "marketing_start_date": "20180402"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (63187-812-15)", "package_ndc": "63187-812-15", "marketing_start_date": "20170202"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (63187-812-20)", "package_ndc": "63187-812-20", "marketing_start_date": "20170202"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE (63187-812-21)", "package_ndc": "63187-812-21", "marketing_start_date": "20170201"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-812-30)", "package_ndc": "63187-812-30", "marketing_start_date": "20170201"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (63187-812-45)", "package_ndc": "63187-812-45", "marketing_start_date": "20170201"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-812-60)", "package_ndc": "63187-812-60", "marketing_start_date": "20170201"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (63187-812-72)", "package_ndc": "63187-812-72", "marketing_start_date": "20180201"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-812-90)", "package_ndc": "63187-812-90", "marketing_start_date": "20170201"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "63187-812_3afe19fb-b693-47f7-a08e-a46cc756ffda", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "63187-812", "generic_name": "Cyclobenzaprine", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090478", "marketing_category": "ANDA", "marketing_start_date": "20160722", "listing_expiration_date": "20261231"}