FDA.reportPublic FDA data

Tizanidine HCL

Product NDC
80425-0090
11-digit product format
804250090
Labeler code
80425
Product ID
80425-0090_453cd7ac-cee0-2b91-e063-6294a90afcdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA210267
Marketing category
ANDA
Marketing start
2019-03-20
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
4 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 HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485485

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
80425-0090-1Tizanidine HCL60 in 1 BOTTLECAPSULE608
80425-0090-2Tizanidine HCL90 in 1 BOTTLECAPSULE908
80425-0090-3Tizanidine HCL30 in 1 BOTTLECAPSULE308
80425-0090-4Tizanidine HCL120 in 1 BOTTLECAPSULE1208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0090-1EA - Each80425-0090fdad67c7-6325-4192-bb88-fe96fbc7804f12023-06-06
80425-0090-2EA - Each80425-0090fa1bee89-d9e8-4b98-9628-f492a2a9d1fa12023-06-06
80425-0090-3EA - Each80425-0090e9da92fe-d9ce-470f-8050-3e64530dc59d12023-04-07
80425-0090-4EA - Each80425-0090cb2031ff-544d-4cad-90a8-d29c6dc5b0b512026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0090TIZANIDINE HCL CAPSULE [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 4 package rows20250101_b353cdb8-75fa-7e3c-e053-2a95a90ada58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485485tiZANidine HCl 4 MG Oral CapsulePSNb353cdb8-75fa-7e3c-e053-2a95a90ada588
485485tizanidine 4 MG Oral CapsuleSCDb353cdb8-75fa-7e3c-e053-2a95a90ada588
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYb353cdb8-75fa-7e3c-e053-2a95a90ada588

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0090-18042500900160 CAPSULE in 1 BOTTLE (80425-0090-1) 60 capsule2019-03-200000-00-00NoNoCurrent
80425-0090-28042500900290 CAPSULE in 1 BOTTLE (80425-0090-2) 90 capsule2019-03-200000-00-00NoNoCurrent
80425-0090-38042500900330 CAPSULE in 1 BOTTLE (80425-0090-3) 30 capsule2019-03-20NoNoCurrent
80425-0090-480425009004120 CAPSULE in 1 BOTTLE (80425-0090-4) 120 capsule2025-12-05NoNoCurrent