FDA.reportPublic FDA data

Tizanidine Hydrochloride

Product NDC
49999-347
11-digit product format
499990347
Labeler code
49999
Product ID
49999-347_adbf3ce7-64fd-4df3-aa6f-9f4b459b2976
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA076286
Marketing category
ANDA
Marketing start
2010-11-23
Marketing end
2027-04-30
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313413

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
49999-347-01Tizanidine Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1203448
49999-347-15Tizanidine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET153448
49999-347-28Tizanidine Hydrochloride28 in 1 BOTTLE, PLASTICTABLET283448
49999-347-30Tizanidine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET303448
49999-347-60Tizanidine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET603448
49999-347-90Tizanidine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET903448

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-347-01EA - Each49999-347badca5f8-fa51-48bc-8155-5bf1474b234312012-07-24
49999-347-15EA - Each49999-347e13002aa-2b97-4ff6-8950-44d6c2dd385312020-01-03
49999-347-28EA - Each49999-3478a6ca07a-902e-4eaf-9457-bd8812c3dc0212012-07-24
49999-347-30EA - Each49999-347e7b1f23e-dedc-4c01-bd48-468ebfc9dc0e12012-07-24
49999-347-60EA - Each49999-3477b9a6eac-3f1f-4ef2-b3a6-a126586f319612012-07-24
49999-347-90EA - Each49999-3471f6812f6-1708-4e31-acf1-7150e046f6b112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3428
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3428

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49999-347TIZANIDINE HYDROCHLORIDE TABLET [QUALITY CARE PRODUCTS LLC]3448Current NDC, Legacy NDC, 6 package rows20241218_87f8a776-e8ae-4aed-a221-98ca72a2bedf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN87f8a776-e8ae-4aed-a221-98ca72a2bedf3448
313413tizanidine 4 MG Oral TabletSCD87f8a776-e8ae-4aed-a221-98ca72a2bedf3448
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY87f8a776-e8ae-4aed-a221-98ca72a2bedf3448

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49999-347-0149999034701120 TABLET in 1 BOTTLE, PLASTIC (49999-347-01) 120 tablet2010-11-232026-10-31NoNoCurrent
49999-347-154999903471515 TABLET in 1 BOTTLE, PLASTIC (49999-347-15) 15 tablet2019-11-190000-00-00NoNoCurrent
49999-347-284999903472828 in 1 BOTTLE, PLASTICHistorical
49999-347-304999903473030 TABLET in 1 BOTTLE, PLASTIC (49999-347-30) 30 tablet2010-11-232027-04-30NoNoCurrent
49999-347-604999903476060 TABLET in 1 BOTTLE, PLASTIC (49999-347-60) 60 tablet2010-11-232027-04-30NoNoCurrent
49999-347-904999903479090 TABLET in 1 BOTTLE, PLASTIC (49999-347-90) 90 tablet2010-11-232027-04-30NoNoCurrent