cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-115
Product ID 72789-115_3416fd46-7b24-04d7-e063-6294a90ae444
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077797
Listing Expiration 2026-12-31
Marketing Start 2017-03-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789115
Hyphenated Format 72789-115

Supplemental Identifiers

RxCUI
828320
UPC
0372789115108
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
  • 5 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-115-10)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-115-20)
source: ndc

Packages (2)

72789-115-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-115-10) 72789-115-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-115-20)

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": "3416fd46-7b24-04d7-e063-6294a90ae444", "openfda": {"upc": ["0372789115108"], "unii": ["0VE05JYS2P"], "rxcui": ["828320"], "spl_set_id": ["59b428fa-5013-4b2b-872f-16ba4a9d4f5d"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-115-10)", "package_ndc": "72789-115-10", "marketing_start_date": "20200914"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-115-20)", "package_ndc": "72789-115-20", "marketing_start_date": "20210119"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "72789-115_3416fd46-7b24-04d7-e063-6294a90ae444", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "72789-115", "generic_name": "cyclobenzaprine hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA077797", "marketing_category": "ANDA", "marketing_start_date": "20170330", "listing_expiration_date": "20261231"}