FDA.reportPublic FDA data

tizanidine hydrochloride

Product NDC
72888-003
11-digit product format
728880003
Labeler code
72888
Product ID
72888-003_3f9bf106-484a-1c3c-e063-6394a90ac8a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA213798
Marketing category
ANDA
Marketing start
2020-05-27
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, 485485, 485486, 2723708

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
72888-003-15tizanidine hydrochloride150 in 1 BOTTLECAPSULE1505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-003-15EA - Each72888-00371732b27-431c-4c3f-8e65-50f28f028c3812021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-003TIZANIDINE HYDROCHLORIDE CAPSULE [ADVAGEN PHARMA LIMITED]4Current NDC, Legacy NDC, 1 package rows20240729_7f39499a-98cf-4d13-9b07-ccb5c22e43c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723708tiZANidine 8 MG Oral CapsulePSN7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485486tiZANidine HCl 2 MG Oral CapsulePSN7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485485tiZANidine HCl 4 MG Oral CapsulePSN7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485484tiZANidine HCl 6 MG Oral CapsulePSN7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485486tizanidine 2 MG Oral CapsuleSCD7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485485tizanidine 4 MG Oral CapsuleSCD7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485484tizanidine 6 MG Oral CapsuleSCD7f39499a-98cf-4d13-9b07-ccb5c22e43c85
2723708tizanidine 8 MG Oral CapsuleSCD7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSY7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY7f39499a-98cf-4d13-9b07-ccb5c22e43c85
2723708tizanidine 8 MG (tizanidine hydrochloride 9.16 MG) Oral CapsuleSY7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485484tiZANidine HCl 6 MG Oral CapsulePSN9d127a0b-b182-4c8a-91a3-311cc936fd4c1
485484tiZANidine HCl 6 MG Oral CapsulePSNe19f83b8-8c59-415c-a744-7473d46ab0ca1
485484tizanidine 6 MG Oral CapsuleSCD9d127a0b-b182-4c8a-91a3-311cc936fd4c1
485484tizanidine 6 MG Oral CapsuleSCDe19f83b8-8c59-415c-a744-7473d46ab0ca1
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY9d127a0b-b182-4c8a-91a3-311cc936fd4c1
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSYe19f83b8-8c59-415c-a744-7473d46ab0ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72888-003-1572888000315150 CAPSULE in 1 BOTTLE (72888-003-15) 150 capsule2020-05-270000-00-00NoNoCurrent