cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler bryant ranch prepack
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 15 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8206
Product ID 63629-8206_9883a891-91a6-4b0c-827d-59bc6b14b0ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021777
Listing Expiration 2026-12-31
Marketing Start 2019-03-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298206
Hyphenated Format 63629-8206

Supplemental Identifiers

RxCUI
828358
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 NDA021777 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8206-1)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8206-2)
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8206-3)
source: ndc

Packages (3)

63629-8206-1 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8206-1) 63629-8206-2 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8206-2) 63629-8206-3 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8206-3)

Ingredients (1)

cyclobenzaprine hydrochloride (15 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": "9883a891-91a6-4b0c-827d-59bc6b14b0ae", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828358"], "spl_set_id": ["2169667d-4f4b-472d-929b-8a0bcbddbe9c"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8206-1)", "package_ndc": "63629-8206-1", "marketing_start_date": "20240708"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8206-2)", "package_ndc": "63629-8206-2", "marketing_start_date": "20240708"}, {"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8206-3)", "package_ndc": "63629-8206-3", "marketing_start_date": "20240708"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "63629-8206_9883a891-91a6-4b0c-827d-59bc6b14b0ae", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "63629-8206", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "NDA021777", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190304", "listing_expiration_date": "20261231"}