FDA.reportPublic FDA data

TONMYA

Product NDC
70792-102
11-digit product format
707920102
Labeler code
70792
Product ID
70792-102_aadca804-560a-4262-843d-2cb4e2fbe851
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
SUBLINGUAL
Labeler
Tonix Medicines, Inc.
Application
NDA219428
Marketing category
NDA
Marketing start
2025-08-15
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
2.8 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TONMYA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE2.8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui2723106, 2723114

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70792-102-14TONMYA14 in 1 BOTTLETABLET, ORALLY DISINTEGRATING143
70792-102-30TONMYA30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING303
70792-102-60TONMYA60 in 1 BOTTLETABLET, ORALLY DISINTEGRATING603
70792-102-90TONMYA90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70792-102-14EA - Each70792-10257716a18-066a-4d35-bea3-4fcd3e96b77412025-11-13
70792-102-30EA - Each70792-102e8853222-9267-4078-b2e5-add01f5bf5bb12025-11-13
70792-102-60EA - Each70792-10218da66a5-65f9-4af0-92a6-577957d32b5612025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723106cyclobenzaprine hydrochloride 2.8 MG Sublingual TabletPSN6fa59588-ce9b-48cf-8c5f-725a448f85713
2723114Tonmya 2.8 MG Sublingual TabletPSN6fa59588-ce9b-48cf-8c5f-725a448f85713
2723114cyclobenzaprine hydrochloride 2.8 MG Sublingual Tablet [Tonmya]SBD6fa59588-ce9b-48cf-8c5f-725a448f85713
2723106cyclobenzaprine hydrochloride 2.8 MG Sublingual TabletSCD6fa59588-ce9b-48cf-8c5f-725a448f85713
2723106cyclobenzaprine hydrochloride 2.8 MG (equivalent to cyclobenzaprine 2.47 MG) Sublingual TabletSY6fa59588-ce9b-48cf-8c5f-725a448f85713
2723114Tonmya 2.8 MG (equivalent to cyclobenzaprine 2.47 MG) Sublingual TabletSY6fa59588-ce9b-48cf-8c5f-725a448f85713
2723114Tonmya 2.8 MG Sublingual TabletSY6fa59588-ce9b-48cf-8c5f-725a448f85713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70792-102-147079201021414 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-14) 2025-09-15YesNoCurrent
70792-102-307079201023030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-30) 2025-10-23YesNoCurrent
70792-102-607079201026060 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-60) 2025-09-15NoNoCurrent
70792-102-907079201029090 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-90) 2025-09-15NoNoCurrent