Ontralfy

Product NDC: 69528-310
Requested package NDC: 69528-310-16
11-digit product format: 695280310
Labeler code: 69528
Product ID: 69528-310_4b1edc20-775b-bb26-e063-6394a90acd08
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tizanidine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Rosemont Pharmaceuticals, LLC
Application: NDA216190
Marketing category: NDA
Marketing start: 2025-03-31
Substance: TIZANIDINE HYDROCHLORIDE
Active strength: 2 mg/5mL
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [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
N216190-001	ONTRALFY	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE/5ML	SOLUTION / ORAL		RLD, RS	2024-12-12

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19
N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15

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	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216190-001	ONTRALFY	EQ 2MG BASE/5ML	SOLUTION / ORAL	RLD, RS	2024-12-12	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216190-001	12042484	2042-05-07	U-2779	Drug product	2024-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216190-001	12263158	2042-05-07	U-2779	Drug product	2025-04-15	`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: Ontralfy
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIZANIDINE HYDROCHLORIDE	2 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B53E3NMY5C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2709432	Internal RxNorm lookup
2709438	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
7b88c338-c0b7-4c08-bef6-a4ffc2f25df7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a0ff02d8-b711-423c-b7d1-ada00d81c743	Product name	1	20250805
9fd28b3a-d1bb-a2ce-ffa3-c3dd28536a01	Product name	8	20250313
b404127e-1c01-47bb-874e-db1e0b6bd9af	Product name	4	20250313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69528-310-16	Ontralfy	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69528-310-16	ML - Milliliter	69528-310	8f29fcbf-5b35-4cce-8e87-bb11693b066d	1	2026-03-17

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
Ontralfy	TIZANIDINE HYDROCHLORIDE	Rosemont Pharmaceuticals, LLC	7b88c338-c0b7-4c08-bef6-a4ffc2f25df7	2025-10-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216190 application number: NDA216190 ndc (package): 69528-310-16 ndc (product): 69528-310 ndc11 (package): 69528031016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B53E3NMY5C	TIZANIDINE HYDROCHLORIDE	64461-82-1	TIZANIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2709438	Ontralfy 2 MG in 5 mL Oral Solution	PSN	7b88c338-c0b7-4c08-bef6-a4ffc2f25df7	2
2709432	tiZANidine 2 MG in 5 mL Oral Solution	PSN	7b88c338-c0b7-4c08-bef6-a4ffc2f25df7	2
2709438	tizanidine 0.4 MG/ML Oral Solution [Ontralfy]	SBD	7b88c338-c0b7-4c08-bef6-a4ffc2f25df7	2
2709432	tizanidine 0.4 MG/ML Oral Solution	SCD	7b88c338-c0b7-4c08-bef6-a4ffc2f25df7	2
2709438	Ontralfy 0.4 MG/ML Oral Solution	SY	7b88c338-c0b7-4c08-bef6-a4ffc2f25df7	2
2709438	Ontralfy 2 MG per 5 mL Oral Solution	SY	7b88c338-c0b7-4c08-bef6-a4ffc2f25df7	2
2709432	tizanidine 2 MG per 5 mL (as tizanidine hydrochloride 2.29 MG per 5 mL) Oral Solution	SY	7b88c338-c0b7-4c08-bef6-a4ffc2f25df7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69528-310-16	69528031016	473 mL in 1 BOTTLE, PLASTIC (69528-310-16)	473 ml	2025-10-01	No	No	Current