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 72789-547
Product ID 72789-547_48ffe51b-f12a-2633-e063-6294a90aaae3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208170
Listing Expiration 2027-12-31
Marketing Start 2017-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789547
Hyphenated Format 72789-547

Supplemental Identifiers

RxCUI
828320
UPC
0372789547213
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 ANDA208170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-547-21)
source: ndc

Packages (1)

72789-547-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-547-21)

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": "48ffe51b-f12a-2633-e063-6294a90aaae3", "openfda": {"upc": ["0372789547213"], "unii": ["0VE05JYS2P"], "rxcui": ["828320"], "spl_set_id": ["4eaa675a-c24c-4043-8fdf-9d59e5e4f4d5"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-547-21)", "package_ndc": "72789-547-21", "marketing_start_date": "20260112"}], "brand_name": "CYCLOBENZAPRINE HYDROCHLORIDE", "product_id": "72789-547_48ffe51b-f12a-2633-e063-6294a90aaae3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "72789-547", "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": "ANDA208170", "marketing_category": "ANDA", "marketing_start_date": "20170531", "listing_expiration_date": "20271231"}