FDA.reportPublic FDA data

Tizanidne hydrochloride

Product NDC
71335-2077
11-digit product format
713352077
Labeler code
71335
Product ID
71335-2077_df974f7d-ae3d-4ca9-b609-a3736e9f46ed
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidne hydrochloride
Listing expiration
2026-12-31

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
71335-2077-1Tizanidne hydrochloride30 in 1 BOTTLECAPSULE30103
71335-2077-2Tizanidne hydrochloride60 in 1 BOTTLECAPSULE60103
71335-2077-3Tizanidne hydrochloride90 in 1 BOTTLECAPSULE90103
71335-2077-4Tizanidne hydrochloride120 in 1 BOTTLECAPSULE120103
71335-2077-5Tizanidne hydrochloride28 in 1 BOTTLECAPSULE28103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2077TIZANIDNE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20231117_649f1f76-da33-4bdf-a38d-5ae3a9cb7987.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485484tiZANidine HCl 6 MG Oral CapsulePSN649f1f76-da33-4bdf-a38d-5ae3a9cb7987103
485484tizanidine 6 MG Oral CapsuleSCD649f1f76-da33-4bdf-a38d-5ae3a9cb7987103
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY649f1f76-da33-4bdf-a38d-5ae3a9cb7987103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2077-17133520770130 CAPSULE in 1 BOTTLE (71335-2077-1) 30 capsule2022-04-250000-00-00NoNoCurrent
71335-2077-27133520770260 CAPSULE in 1 BOTTLE (71335-2077-2) 60 capsule2022-04-250000-00-00NoNoCurrent
71335-2077-37133520770390 CAPSULE in 1 BOTTLE (71335-2077-3) 90 capsule2022-04-250000-00-00NoNoCurrent
71335-2077-471335207704120 CAPSULE in 1 BOTTLE (71335-2077-4) 120 capsule2022-04-250000-00-00NoNoCurrent
71335-2077-57133520770528 CAPSULE in 1 BOTTLE (71335-2077-5) 28 capsule2022-04-250000-00-00NoNoCurrent