tonmya

Generic: cyclobenzaprine hydrochloride

Labeler: tonix medicines, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tonmya
Generic Name cyclobenzaprine hydrochloride
Labeler tonix medicines, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
SUBLINGUAL
Active Ingredients

cyclobenzaprine hydrochloride 2.8 mg/1

Manufacturer
Tonix Medicines, Inc.

Identifiers & Regulatory

Product NDC 70792-102
Product ID 70792-102_aadca804-560a-4262-843d-2cb4e2fbe851
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219428
Listing Expiration 2026-12-31
Marketing Start 2025-08-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70792102
Hyphenated Format 70792-102

Supplemental Identifiers

RxCUI
2723106 2723114
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 tonmya (source: ndc)
Generic Name cyclobenzaprine hydrochloride (source: ndc)
Application Number NDA219428 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 2.8 mg/1
source: ndc
Packaging
  • 14 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-14)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-30)
  • 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-60)
  • 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-90)
source: ndc

Packages (4)

70792-102-14 14 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-14) 70792-102-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-30) 70792-102-60 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-60) 70792-102-90 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-90)

Ingredients (1)

cyclobenzaprine hydrochloride (2.8 mg/1)

Linked Drug Pages (1)

TONMYA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "aadca804-560a-4262-843d-2cb4e2fbe851", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["2723106", "2723114"], "spl_set_id": ["6fa59588-ce9b-48cf-8c5f-725a448f8571"], "manufacturer_name": ["Tonix Medicines, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "14 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-14)", "package_ndc": "70792-102-14", "marketing_start_date": "20250915"}, {"sample": true, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-30)", "package_ndc": "70792-102-30", "marketing_start_date": "20251023"}, {"sample": false, "description": "60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-60)", "package_ndc": "70792-102-60", "marketing_start_date": "20250915"}, {"sample": false, "description": "90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-90)", "package_ndc": "70792-102-90", "marketing_start_date": "20250915"}], "brand_name": "TONMYA", "product_id": "70792-102_aadca804-560a-4262-843d-2cb4e2fbe851", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "70792-102", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Tonix Medicines, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TONMYA", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "2.8 mg/1"}], "application_number": "NDA219428", "marketing_category": "NDA", "marketing_start_date": "20250815", "listing_expiration_date": "20261231"}