FDA.reportPublic FDA data

TIZANIDINE HYDROCHLORIDE

Product NDC
50742-226
11-digit product format
507420226
Labeler code
50742
Product ID
50742-226_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
6 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 HYDROCHLORIDE6 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
50742-226-15TIZANIDINE HYDROCHLORIDE150 in 1 BOTTLE, PLASTICCAPSULE1508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-226-15EA - Each50742-2268480bdec-d582-4c55-8a3a-6cb2814dd25f12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-226TIZANIDINE 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
485484tiZANidine HCl 6 MG Oral CapsulePSNff7a82ea-c03c-44f6-9b15-468cb8d15a9c101
485484tizanidine 6 MG Oral CapsuleSCDff7a82ea-c03c-44f6-9b15-468cb8d15a9c101
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSYff7a82ea-c03c-44f6-9b15-468cb8d15a9c101
485486tiZANidine HCl 2 MG Oral CapsulePSN99cc8f5f-b947-4ddc-99b6-1e4cef09b7178
485485tiZANidine HCl 4 MG Oral CapsulePSN99cc8f5f-b947-4ddc-99b6-1e4cef09b7178
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
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
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY99cc8f5f-b947-4ddc-99b6-1e4cef09b7178
485484tiZANidine HCl 6 MG Oral CapsulePSN0bdc188d-b895-acbc-e063-6294a90acd684
485484tizanidine 6 MG Oral CapsuleSCD0bdc188d-b895-acbc-e063-6294a90acd684
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY0bdc188d-b895-acbc-e063-6294a90acd684
485484tiZANidine HCl 6 MG Oral CapsulePSNae9b6808-632f-4204-8581-bf146dcab69f3
485484tizanidine 6 MG Oral CapsuleSCDae9b6808-632f-4204-8581-bf146dcab69f3
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSYae9b6808-632f-4204-8581-bf146dcab69f3
485484tiZANidine HCl 6 MG Oral CapsulePSN4009c6cb-c183-2165-e063-6294a90aed781
485484tiZANidine HCl 6 MG Oral CapsulePSN26f8f233-5dc2-0013-e063-6394a90ab0f51
485484tizanidine 6 MG Oral CapsuleSCD4009c6cb-c183-2165-e063-6294a90aed781
485484tizanidine 6 MG Oral CapsuleSCD26f8f233-5dc2-0013-e063-6394a90ab0f51
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY4009c6cb-c183-2165-e063-6294a90aed781
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY26f8f233-5dc2-0013-e063-6394a90ab0f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-226-1550742022615150 CAPSULE in 1 BOTTLE, PLASTIC (50742-226-15) 150 capsule2019-03-200000-00-00NoNoCurrent