cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-753
Product ID 68084-753_292934aa-0e3e-af97-e063-6394a90ae5b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078048
Listing Expiration 2026-12-31
Marketing Start 2016-01-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084753
Hyphenated Format 68084-753

Supplemental Identifiers

RxCUI
828320
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 ANDA078048 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-753-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-753-95)
  • 50 BLISTER PACK in 1 CARTON (68084-753-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-753-11)
source: ndc

Packages (2)

68084-753-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-753-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-753-95) 68084-753-65 50 BLISTER PACK in 1 CARTON (68084-753-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-753-11)

Ingredients (1)

cyclobenzaprine hydrochloride (5 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": "292934aa-0e3e-af97-e063-6394a90ae5b4", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320"], "spl_set_id": ["5f321a03-ccfb-4c11-ac60-a461a5580c69"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-753-25)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-753-95)", "package_ndc": "68084-753-25", "marketing_start_date": "20160104"}, {"sample": false, "description": "50 BLISTER PACK in 1 CARTON (68084-753-65)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-753-11)", "package_ndc": "68084-753-65", "marketing_start_date": "20240327"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "68084-753_292934aa-0e3e-af97-e063-6394a90ae5b4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "68084-753", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA078048", "marketing_category": "ANDA", "marketing_start_date": "20160104", "listing_expiration_date": "20261231"}