TONMYA

Product NDC: 70792-102
Requested package NDC: 70792-102-90
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219428-001	TONMYA	CYCLOBENZAPRINE HYDROCHLORIDE	2.8MG	TABLET / SUBLINGUAL		RLD, RS	2025-08-15

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N219428-001	10117936	2034-03-14	Drug product	2025-09-19
N219428-001	10864175	2034-03-14	Drug product	2025-09-19
N219428-001	9636408	2034-03-14	Drug product	2025-09-19
N219428-001	9956188	2034-03-14	Drug product	2025-09-19

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219428-001	NP	2028-08-15

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N219428-001	TONMYA	2.8MG	TABLET / SUBLINGUAL	RLD, RS	2025-08-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219428-001	TONMYA	2.8MG	TABLET / SUBLINGUAL	RLD, RS	2025-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219428-001	TONMYA	2.8MG	TABLET / SUBLINGUAL	RLD, RS	2025-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219428-001	TONMYA	2.8MG	TABLET / SUBLINGUAL	RLD, RS	2025-08-15	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219428-001	TONMYA	2.8MG	TABLET / SUBLINGUAL	RLD, RS	2025-08-15	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N219428-001	10117936	2034-03-14	Drug product	2025-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219428-001	10864175	2034-03-14	Drug product	2025-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219428-001	9636408	2034-03-14	Drug product	2025-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219428-001	9956188	2034-03-14	Drug product	2025-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219428-001	10117936	2034-03-14	Drug product	2025-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219428-001	10864175	2034-03-14	Drug product	2025-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219428-001	9636408	2034-03-14	Drug product	2025-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219428-001	9956188	2034-03-14	Drug product	2025-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219428-001	10117936	2034-03-14	Drug product	2025-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219428-001	10864175	2034-03-14	Drug product	2025-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219428-001	9636408	2034-03-14	Drug product	2025-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219428-001	9956188	2034-03-14	Drug product	2025-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219428-001	10117936	2034-03-14	Drug product	2025-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219428-001	10864175	2034-03-14	Drug product	2025-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219428-001	9636408	2034-03-14	Drug product	2025-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219428-001	9956188	2034-03-14	Drug product	2025-09-19	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219428-001	10117936	2034-03-14	Drug product	2025-09-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219428-001	10864175	2034-03-14	Drug product	2025-09-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219428-001	9636408	2034-03-14	Drug product	2025-09-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219428-001	9956188	2034-03-14	Drug product	2025-09-19	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N219428-001	NP	2028-08-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219428-001	NP	2028-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219428-001	NP	2028-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219428-001	NP	2028-08-15	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219428-001	NP	2028-08-15	`a50c72e98297…`

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
Ingredient	Strength
CYCLOBENZAPRINE HYDROCHLORIDE	2.8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0VE05JYS2P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
6fa59588-ce9b-48cf-8c5f-725a448f8571	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
51048710-225c-aa41-d0e7-eed095d02838	Product name	4	20250331
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
c2c26dc9-7e16-fc02-7eba-6b46ed3515ee	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70792-102-14	TONMYA	14 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	14	3
70792-102-30	TONMYA	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30	3
70792-102-60	TONMYA	60 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	60	3
70792-102-90	TONMYA	90 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70792-102-14	EA - Each	70792-102	57716a18-066a-4d35-bea3-4fcd3e96b774	1	2025-11-13
70792-102-30	EA - Each	70792-102	e8853222-9267-4078-b2e5-add01f5bf5bb	1	2025-11-13
70792-102-60	EA - Each	70792-102	18da66a5-65f9-4af0-92a6-577957d32b56	1	2025-11-13

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TONMYA	CYCLOBENZAPRINE HYDROCHLORIDE	Tonix Medicines, Inc.	6fa59588-ce9b-48cf-8c5f-725a448f8571	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219428 application number: NDA219428 ndc (package): 70792-102-90 ndc (product): 70792-102 ndc11 (package): 70792010290

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE	6202-23-9	CYCLOBENZAPRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2723106	cyclobenzaprine hydrochloride 2.8 MG Sublingual Tablet	PSN	6fa59588-ce9b-48cf-8c5f-725a448f8571	3
2723114	Tonmya 2.8 MG Sublingual Tablet	PSN	6fa59588-ce9b-48cf-8c5f-725a448f8571	3
2723114	cyclobenzaprine hydrochloride 2.8 MG Sublingual Tablet [Tonmya]	SBD	6fa59588-ce9b-48cf-8c5f-725a448f8571	3
2723106	cyclobenzaprine hydrochloride 2.8 MG Sublingual Tablet	SCD	6fa59588-ce9b-48cf-8c5f-725a448f8571	3
2723106	cyclobenzaprine hydrochloride 2.8 MG (equivalent to cyclobenzaprine 2.47 MG) Sublingual Tablet	SY	6fa59588-ce9b-48cf-8c5f-725a448f8571	3
2723114	Tonmya 2.8 MG (equivalent to cyclobenzaprine 2.47 MG) Sublingual Tablet	SY	6fa59588-ce9b-48cf-8c5f-725a448f8571	3
2723114	Tonmya 2.8 MG Sublingual Tablet	SY	6fa59588-ce9b-48cf-8c5f-725a448f8571	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70792-102-90	70792010290	90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-90)	2025-09-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TONMYA	Tonix Medicines, Inc. \| Tonix Pharmaceuticals, Inc. \| Almac Pharma Services Limited \| Patheon Inc.	2026-08-14	HUMAN PRESCRIPTION DRUG LABEL	5