TIZANIDINE HYDROCHLORIDE

Product NDC
60760-892
11-digit product format
607600892
Labeler code
60760
Product ID
60760-892_4009c0a9-d2e0-3595-e063-6294a90aa2a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
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

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
60760-892-30TIZANIDINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-892-30EA - Each60760-892a36c308e-a9a0-4751-b3c7-288db4474c6812025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485484tiZANidine HCl 6 MG Oral CapsulePSN4009c6cb-c183-2165-e063-6294a90aed781
485484tizanidine 6 MG Oral CapsuleSCD4009c6cb-c183-2165-e063-6294a90aed781
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY4009c6cb-c183-2165-e063-6294a90aed781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-892-306076008923030 CAPSULE in 1 BOTTLE, PLASTIC (60760-892-30) 30 capsule2025-09-30NoNoCurrent