cyclobenzaprine hydrochloride

Generic: cyclobenzaprine

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

Drug Facts

Product Profile

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

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-558
Product ID 60687-558_437e4fe5-baf0-1534-e063-6394a90a22d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090478
Listing Expiration 2026-12-31
Marketing Start 2022-02-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687558
Hyphenated Format 60687-558

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 (source: ndc)
Application Number ANDA090478 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (60687-558-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-558-11)
source: ndc

Packages (1)

60687-558-01 100 BLISTER PACK in 1 CARTON (60687-558-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-558-11)

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": "437e4fe5-baf0-1534-e063-6394a90a22d4", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["269bc278-963d-4830-816a-39bb4bf8c936"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (60687-558-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-558-11)", "package_ndc": "60687-558-01", "marketing_start_date": "20220210"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "60687-558_437e4fe5-baf0-1534-e063-6394a90a22d4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "60687-558", "generic_name": "Cyclobenzaprine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090478", "marketing_category": "ANDA", "marketing_start_date": "20220210", "listing_expiration_date": "20261231"}