cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler coupler llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1566
Product ID 67046-1566_37c8c986-5a0b-ec3c-e063-6294a90a5df2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208170
Listing Expiration 2026-12-31
Marketing Start 2025-06-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461566
Hyphenated Format 67046-1566

Supplemental Identifiers

RxCUI
828348
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 ANDA208170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1566-3)
source: ndc

Packages (1)

67046-1566-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1566-3)

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": "37c8c986-5a0b-ec3c-e063-6294a90a5df2", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["37c8c0d6-98c0-c1a5-e063-6394a90a7931"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1566-3)", "package_ndc": "67046-1566-3", "marketing_start_date": "20250617"}], "brand_name": "CYCLOBENZAPRINE HYDROCHLORIDE", "product_id": "67046-1566_37c8c986-5a0b-ec3c-e063-6294a90a5df2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "67046-1566", "generic_name": "cyclobenzaprine hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CYCLOBENZAPRINE HYDROCHLORIDE", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA208170", "marketing_category": "ANDA", "marketing_start_date": "20250617", "listing_expiration_date": "20261231"}