FDA.reportPublic FDA data

Tizanidne hydrochloride

Product NDC
76420-231
11-digit product format
764200231
Labeler code
76420
Product ID
76420-231_e347f58a-9fc4-7e64-e053-2a95a90a528b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidne Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
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
76420-231-30Tizanidne hydrochloride30 in 1 BOTTLECAPSULE301
76420-231-60Tizanidne hydrochloride60 in 1 BOTTLECAPSULE601
76420-231-90Tizanidne hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-231-30EA - Each76420-231c154f505-9313-4f47-aef1-64676b5a834812022-08-04
76420-231-60EA - Each76420-2310ccd0a85-ee95-40b9-9023-3608a3591aad12022-08-04
76420-231-90EA - Each76420-231261ad0b9-c8fd-4e0b-a5dc-58c4de0c566c12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-231TIZANIDNE HYDROCHLORIDE (TIZANIDNE HYDROCHLORIDE) CAPSULE [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 3 package rows20220710_1ad6eaf6-bd32-4d05-bdd0-a6246e2afb9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485484tiZANidine HCl 6 MG Oral CapsulePSN1ad6eaf6-bd32-4d05-bdd0-a6246e2afb9c1
485484tizanidine 6 MG Oral CapsuleSCD1ad6eaf6-bd32-4d05-bdd0-a6246e2afb9c1
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY1ad6eaf6-bd32-4d05-bdd0-a6246e2afb9c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-231-307642002313030 CAPSULE in 1 BOTTLE (76420-231-30) 30 capsule2022-07-070000-00-00NoNoCurrent
76420-231-607642002316060 CAPSULE in 1 BOTTLE (76420-231-60) 60 capsule2022-07-070000-00-00NoNoCurrent
76420-231-907642002319090 CAPSULE in 1 BOTTLE (76420-231-90) 90 capsule2022-07-070000-00-00NoNoCurrent