FDA.reportPublic FDA data

TIZANIDINE HYDROCHLORIDE

Product NDC
50742-225
11-digit product format
507420225
Labeler code
50742
Product ID
50742-225_6b60abcf-1c7f-42f4-85df-1d80fed36d54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA210267
Marketing category
ANDA
Marketing start
2019-03-20
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485484, 485485, 485486

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
50742-225-15TIZANIDINE HYDROCHLORIDE150 in 1 BOTTLE, PLASTICCAPSULE1508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-225-15EA - Each50742-22594740035-1ec6-4643-87da-6690d62b662012019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-225TIZANIDINE HYDROCHLORIDE CAPSULE [INGENUS PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 1 package rows20231020_99cc8f5f-b947-4ddc-99b6-1e4cef09b717.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485486tiZANidine HCl 2 MG Oral CapsulePSN99cc8f5f-b947-4ddc-99b6-1e4cef09b7178
485485tiZANidine HCl 4 MG Oral CapsulePSN99cc8f5f-b947-4ddc-99b6-1e4cef09b7178
485485tiZANidine HCl 4 MG Oral CapsulePSNb353cdb8-75fa-7e3c-e053-2a95a90ada588
485484tiZANidine HCl 6 MG Oral CapsulePSN99cc8f5f-b947-4ddc-99b6-1e4cef09b7178
485486tizanidine 2 MG Oral CapsuleSCD99cc8f5f-b947-4ddc-99b6-1e4cef09b7178
485485tizanidine 4 MG Oral CapsuleSCD99cc8f5f-b947-4ddc-99b6-1e4cef09b7178
485485tizanidine 4 MG Oral CapsuleSCDb353cdb8-75fa-7e3c-e053-2a95a90ada588
485484tizanidine 6 MG Oral CapsuleSCD99cc8f5f-b947-4ddc-99b6-1e4cef09b7178
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSY99cc8f5f-b947-4ddc-99b6-1e4cef09b7178
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY99cc8f5f-b947-4ddc-99b6-1e4cef09b7178
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYb353cdb8-75fa-7e3c-e053-2a95a90ada588
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY99cc8f5f-b947-4ddc-99b6-1e4cef09b7178
485485tiZANidine HCl 4 MG Oral CapsulePSN6439a7ef-1b22-4fa1-9be3-eedd3cd241912
485485tizanidine 4 MG Oral CapsuleSCD6439a7ef-1b22-4fa1-9be3-eedd3cd241912
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY6439a7ef-1b22-4fa1-9be3-eedd3cd241912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-225-1550742022515150 CAPSULE in 1 BOTTLE, PLASTIC (50742-225-15) 150 capsule2019-03-200000-00-00NoNoCurrent