Tizanidne hydrochloride

Product NDC
72162-1861
11-digit product format
721621861
Labeler code
72162
Product ID
72162-1861_b6d64e2d-3e76-4069-864e-5e898d7e4312
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidne hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212196
Marketing category
ANDA
Marketing start
2019-03-29
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485485

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
72162-1861-2Tizanidne hydrochloride150 in 1 BOTTLECAPSULE150101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1861-2EA - Each72162-1861a83747c3-0830-4d8f-8cae-3d40d1cf0e5f12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1861TIZANIDNE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240308_04febb37-00d6-4279-8c5f-171950278c8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485485tiZANidine HCl 4 MG Oral CapsulePSN04febb37-00d6-4279-8c5f-171950278c8f101
485485tizanidine 4 MG Oral CapsuleSCD04febb37-00d6-4279-8c5f-171950278c8f101
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY04febb37-00d6-4279-8c5f-171950278c8f101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1861-272162186102150 CAPSULE in 1 BOTTLE (72162-1861-2) 150 capsule2019-03-29NoNoHistorical