cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: pharmasource meds, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
Pharmasource Meds, LLC

Identifiers & Regulatory

Product NDC 82982-027
Product ID 82982-027_198ca554-e360-5da4-e063-6294a90adf71
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077797
Marketing Start 2023-03-08
Marketing End 2026-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82982027
Hyphenated Format 82982-027

Supplemental Identifiers

RxCUI
828348
UPC
0382982027306
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 ANDA077797 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (82982-027-30)
source: ndc

Packages (1)

82982-027-30 30 TABLET, FILM COATED in 1 BOTTLE (82982-027-30)

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": "198ca554-e360-5da4-e063-6294a90adf71", "openfda": {"upc": ["0382982027306"], "unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["f5633c0d-bcf3-b9f6-e053-2a95a90a9353"], "manufacturer_name": ["Pharmasource Meds, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (82982-027-30)", "package_ndc": "82982-027-30", "marketing_end_date": "20260331", "marketing_start_date": "20230308"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "82982-027_198ca554-e360-5da4-e063-6294a90adf71", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "82982-027", "generic_name": "cyclobenzaprine hydrochloride", "labeler_name": "Pharmasource Meds, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA077797", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20230308"}