Tizanidne hydrochloride

Product NDC
72162-1862
11-digit product format
721621862
Labeler code
72162
Product ID
72162-1862_03d1cb61-d725-4f61-9918-ac0d2750e270
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
6 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 HYDROCHLORIDE6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485484

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
72162-1862-2Tizanidne hydrochloride150 in 1 BOTTLECAPSULE150101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1862-2EA - Each72162-18628911f820-9567-4f73-9aa8-e2bb85977a2f12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1862TIZANIDNE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240308_31b40276-099b-482c-a13c-8fbbf1ebc50a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485484tiZANidine HCl 6 MG Oral CapsulePSN31b40276-099b-482c-a13c-8fbbf1ebc50a101
485484tizanidine 6 MG Oral CapsuleSCD31b40276-099b-482c-a13c-8fbbf1ebc50a101
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY31b40276-099b-482c-a13c-8fbbf1ebc50a101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1862-272162186202150 CAPSULE in 1 BOTTLE (72162-1862-2) 150 capsule2019-03-29NoNoHistorical