cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: preferred pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler preferred pharmaceuticals, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 15 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8522
Product ID 68788-8522_d7bcfd6d-30cd-4dc5-8fac-4298b7d4f3a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091281
Listing Expiration 2026-12-31
Marketing Start 2023-09-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888522
Hyphenated Format 68788-8522

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 ANDA091281 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8522-3)
source: ndc

Packages (1)

68788-8522-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8522-3)

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": "d7bcfd6d-30cd-4dc5-8fac-4298b7d4f3a9", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828358"], "spl_set_id": ["550d3e5a-c95f-4094-a500-1a02ea35a18d"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8522-3)", "package_ndc": "68788-8522-3", "marketing_start_date": "20230912"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "68788-8522_d7bcfd6d-30cd-4dc5-8fac-4298b7d4f3a9", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "68788-8522", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Preferred Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA091281", "marketing_category": "ANDA", "marketing_start_date": "20230912", "listing_expiration_date": "20261231"}