cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: kvk-tech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler kvk-tech, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
KVK-TECH, Inc.

Identifiers & Regulatory

Product NDC 10702-006
Product ID 10702-006_7d541fa9-d74b-5236-e053-2991aa0acc0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078048
Listing Expiration 2026-12-31
Marketing Start 2014-07-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10702006
Hyphenated Format 10702-006

Supplemental Identifiers

RxCUI
828320 828348
UNII
0VE05JYS2P

Packaging Origin

Original Packager
true

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
  • 100 TABLET, FILM COATED in 1 BOTTLE (10702-006-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (10702-006-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE (10702-006-50)
source: ndc

Packages (3)

10702-006-01 100 TABLET, FILM COATED in 1 BOTTLE (10702-006-01) 10702-006-10 1000 TABLET, FILM COATED in 1 BOTTLE (10702-006-10) 10702-006-50 500 TABLET, FILM COATED in 1 BOTTLE (10702-006-50)

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": "7d541fa9-d74b-5236-e053-2991aa0acc0e", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320", "828348"], "spl_set_id": ["5b756c04-e7b8-4efe-815a-3f3e020727fb"], "manufacturer_name": ["KVK-TECH, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (10702-006-01)", "package_ndc": "10702-006-01", "marketing_start_date": "20140731"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (10702-006-10)", "package_ndc": "10702-006-10", "marketing_start_date": "20140731"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (10702-006-50)", "package_ndc": "10702-006-50", "marketing_start_date": "20140731"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "10702-006_7d541fa9-d74b-5236-e053-2991aa0acc0e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "10702-006", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "KVK-TECH, Inc.", "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": "20140731", "listing_expiration_date": "20261231"}