cyclobenzaprine hcl

Generic: cyclobenzaprine hcl

Labeler: phoenix rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hcl
Generic Name cyclobenzaprine hcl
Labeler phoenix rx llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 7.5 mg/1

Manufacturer
PHOENIX RX LLC

Identifiers & Regulatory

Product NDC 85509-1001
Product ID 85509-1001_488202dc-28f3-ad46-e063-6294a90a4238
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078722
Listing Expiration 2027-12-31
Marketing Start 2015-03-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 855091001
Hyphenated Format 85509-1001

Supplemental Identifiers

RxCUI
828299
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 hcl (source: ndc)
Generic Name cyclobenzaprine hcl (source: ndc)
Application Number ANDA078722 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (85509-1001-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (85509-1001-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (85509-1001-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (85509-1001-9)
source: ndc

Packages (4)

85509-1001-1 120 TABLET, FILM COATED in 1 BOTTLE (85509-1001-1) 85509-1001-3 30 TABLET, FILM COATED in 1 BOTTLE (85509-1001-3) 85509-1001-6 60 TABLET, FILM COATED in 1 BOTTLE (85509-1001-6) 85509-1001-9 90 TABLET, FILM COATED in 1 BOTTLE (85509-1001-9)

Ingredients (1)

cyclobenzaprine hydrochloride (7.5 mg/1)

Linked Drug Pages (1)

Cyclobenzaprine HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "488202dc-28f3-ad46-e063-6294a90a4238", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828299"], "spl_set_id": ["3a397e88-d267-feed-e063-6294a90a7710"], "manufacturer_name": ["PHOENIX RX LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (85509-1001-1)", "package_ndc": "85509-1001-1", "marketing_start_date": "20250721"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (85509-1001-3)", "package_ndc": "85509-1001-3", "marketing_start_date": "20250721"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (85509-1001-6)", "package_ndc": "85509-1001-6", "marketing_start_date": "20250721"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (85509-1001-9)", "package_ndc": "85509-1001-9", "marketing_start_date": "20250721"}], "brand_name": "Cyclobenzaprine HCL", "product_id": "85509-1001_488202dc-28f3-ad46-e063-6294a90a4238", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "85509-1001", "generic_name": "Cyclobenzaprine HCL", "labeler_name": "PHOENIX RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine HCL", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA078722", "marketing_category": "ANDA", "marketing_start_date": "20150325", "listing_expiration_date": "20271231"}