cyclobenzaprine hydrochloride

Generic: cyclobenzaprine

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine
Labeler cipla usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-845
Product ID 69097-845_0e5c376d-9599-4825-9226-016d40cf6113
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090478
Listing Expiration 2026-12-31
Marketing Start 2016-07-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097845
Hyphenated Format 69097-845

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

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (69097-845-07)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (69097-845-15)
source: ndc

Packages (2)

69097-845-07 100 TABLET, FILM COATED in 1 BOTTLE (69097-845-07) 69097-845-15 1000 TABLET, FILM COATED in 1 BOTTLE (69097-845-15)

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": "0e5c376d-9599-4825-9226-016d40cf6113", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320", "828348"], "spl_set_id": ["575a31fb-04c5-4001-88a7-c33adbacc6a8"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69097-845-07)", "package_ndc": "69097-845-07", "marketing_start_date": "20160722"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (69097-845-15)", "package_ndc": "69097-845-15", "marketing_start_date": "20160722"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "69097-845_0e5c376d-9599-4825-9226-016d40cf6113", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "69097-845", "generic_name": "Cyclobenzaprine", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090478", "marketing_category": "ANDA", "marketing_start_date": "20160722", "listing_expiration_date": "20261231"}