FDA.reportPublic FDA data

Ontralfy

Product NDC
69528-310
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE2 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui2709432, 2709438

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0ff02d8-b711-423c-b7d1-ada00d81c743Product name120250805
9fd28b3a-d1bb-a2ce-ffa3-c3dd28536a01Product name820250313
b404127e-1c01-47bb-874e-db1e0b6bd9afProduct name420250313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69528-310-16Ontralfy473 mL in 1 BOTTLE, PLASTICSOLUTION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69528-310-16ML - Milliliter69528-3108f29fcbf-5b35-4cce-8e87-bb11693b066d12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2709438Ontralfy 2 MG in 5 mL Oral SolutionPSN7b88c338-c0b7-4c08-bef6-a4ffc2f25df72
2709432tiZANidine 2 MG in 5 mL Oral SolutionPSN7b88c338-c0b7-4c08-bef6-a4ffc2f25df72
2709438tizanidine 0.4 MG/ML Oral Solution [Ontralfy]SBD7b88c338-c0b7-4c08-bef6-a4ffc2f25df72
2709432tizanidine 0.4 MG/ML Oral SolutionSCD7b88c338-c0b7-4c08-bef6-a4ffc2f25df72
2709438Ontralfy 0.4 MG/ML Oral SolutionSY7b88c338-c0b7-4c08-bef6-a4ffc2f25df72
2709438Ontralfy 2 MG per 5 mL Oral SolutionSY7b88c338-c0b7-4c08-bef6-a4ffc2f25df72
2709432tizanidine 2 MG per 5 mL (as tizanidine hydrochloride 2.29 MG per 5 mL) Oral SolutionSY7b88c338-c0b7-4c08-bef6-a4ffc2f25df72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69528-310-1669528031016473 mL in 1 BOTTLE, PLASTIC (69528-310-16) 473 ml2025-10-01NoNoCurrent