FDA.reportPublic FDA data

TONMYA

Product NDC
70792-102
11-digit product format
707920102
Labeler code
70792
Product ID
70792-102_c3457853-101e-46ee-899a-1f7539017eab
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219428-001TONMYACYCLOBENZAPRINE HYDROCHLORIDE2.8MGTABLET / SUBLINGUALRLD, RS2025-08-15

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219428-001101179362034-03-14Drug product2025-09-19
N219428-001108641752034-03-14Drug product2025-09-19
N219428-00196364082034-03-14Drug product2025-09-19
N219428-00199561882034-03-14Drug product2025-09-19

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219428-001NP2028-08-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N219428-001TONMYA2.8MGTABLET / SUBLINGUALRLD, RS2025-08-1584e616aacf4f…
2026-08-18 06:07:402026-07N219428-001TONMYA2.8MGTABLET / SUBLINGUALRLD, RS2025-08-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219428-001TONMYA2.8MGTABLET / SUBLINGUALRLD, RS2025-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219428-001TONMYA2.8MGTABLET / SUBLINGUALRLD, RS2025-08-1531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219428-001TONMYA2.8MGTABLET / SUBLINGUALRLD, RS2025-08-15a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N219428-001101179362034-03-14Drug product2025-09-1984e616aacf4f…
2026-09-14 22:38:342026-08N219428-001108641752034-03-14Drug product2025-09-1984e616aacf4f…
2026-09-14 22:38:342026-08N219428-00196364082034-03-14Drug product2025-09-1984e616aacf4f…
2026-09-14 22:38:342026-08N219428-00199561882034-03-14Drug product2025-09-1984e616aacf4f…
2026-08-18 06:07:402026-07N219428-001101179362034-03-14Drug product2025-09-19caaa826d4ba7…
2026-08-18 06:07:402026-07N219428-001108641752034-03-14Drug product2025-09-19caaa826d4ba7…
2026-08-18 06:07:402026-07N219428-00196364082034-03-14Drug product2025-09-19caaa826d4ba7…
2026-08-18 06:07:402026-07N219428-00199561882034-03-14Drug product2025-09-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219428-001101179362034-03-14Drug product2025-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219428-001108641752034-03-14Drug product2025-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219428-00196364082034-03-14Drug product2025-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219428-00199561882034-03-14Drug product2025-09-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219428-001101179362034-03-14Drug product2025-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219428-001108641752034-03-14Drug product2025-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219428-00196364082034-03-14Drug product2025-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219428-00199561882034-03-14Drug product2025-09-1931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219428-001101179362034-03-14Drug product2025-09-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219428-001108641752034-03-14Drug product2025-09-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219428-00196364082034-03-14Drug product2025-09-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219428-00199561882034-03-14Drug product2025-09-19a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N219428-001NP2028-08-1584e616aacf4f…
2026-08-18 06:07:402026-07N219428-001NP2028-08-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219428-001NP2028-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219428-001NP2028-08-1531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219428-001NP2028-08-15a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
TONMYA
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0VE05JYS2PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2723106Internal RxNorm lookup
2723114Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6fa59588-ce9b-48cf-8c5f-725a448f8571Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TONMYACYCLOBENZAPRINE HYDROCHLORIDETonix Medicines, Inc.6fa59588-ce9b-48cf-8c5f-725a448f85712026-08-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 219428
application number: NDA219428
ndc (product): 70792-102

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) 2025-09-15NoNoCurrent
70792-102-307079201023030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-30) 2025-10-23NoNoCurrent
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