cyclobenzaprine hcl er

Generic: cyclobenzaprine hcl

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hcl er
Generic Name cyclobenzaprine hcl
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 15 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0292
Product ID 80425-0292_2a9bfe6a-6d67-b262-e063-6294a90a1cf3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021777
Listing Expiration 2026-12-31
Marketing Start 2023-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250292
Hyphenated Format 80425-0292

Supplemental Identifiers

RxCUI
828358
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 er (source: ndc)
Generic Name cyclobenzaprine hcl (source: ndc)
Application Number NDA021777 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-1)
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-2)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-3)
source: ndc

Packages (3)

80425-0292-1 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-1) 80425-0292-2 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-2) 80425-0292-3 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-3)

Ingredients (1)

cyclobenzaprine hydrochloride (15 mg/1)

Linked Drug Pages (1)

Cyclobenzaprine HCL ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a9bfe6a-6d67-b262-e063-6294a90a1cf3", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828358"], "spl_set_id": ["f8360da5-f1d3-1d89-e053-6294a90ad31c"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-1)", "package_ndc": "80425-0292-1", "marketing_start_date": "20230331"}, {"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-2)", "package_ndc": "80425-0292-2", "marketing_start_date": "20230331"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-3)", "package_ndc": "80425-0292-3", "marketing_start_date": "20230331"}], "brand_name": "Cyclobenzaprine HCL ER", "product_id": "80425-0292_2a9bfe6a-6d67-b262-e063-6294a90a1cf3", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "80425-0292", "generic_name": "Cyclobenzaprine HCL", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine HCL", "brand_name_suffix": "ER", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "NDA021777", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230331", "listing_expiration_date": "20261231"}