FDA.reportPublic FDA data

tizanidine

Product NDC
70771-1335
11-digit product format
707711335
Labeler code
70771
Product ID
70771-1335_d046bff9-82fd-4905-ba58-b955f5a608d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA208187
Marketing category
ANDA
Marketing start
2018-09-13
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
2 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313412, 313413

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
70771-1335-0tizanidine1000 in 1 BOTTLETABLET10007
70771-1335-2tizanidine10 in 1 BLISTER PACKTABLET107
70771-1335-3tizanidine30 in 1 BOTTLETABLET307
70771-1335-4tizanidine10 in 1 CARTONTABLET107
70771-1335-8tizanidine150 in 1 BOTTLETABLET1507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1335TIZANIDINE TABLET [ZYDUS LIFESCIENCES LIMITED]7Current NDC, Legacy NDC, 5 package rows20241220_89105a78-badb-469e-966e-195fa3a53f0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN89105a78-badb-469e-966e-195fa3a53f0a7
313413tiZANidine HCl 4 MG Oral TabletPSN89105a78-badb-469e-966e-195fa3a53f0a7
313412tizanidine 2 MG Oral TabletSCD89105a78-badb-469e-966e-195fa3a53f0a7
313413tizanidine 4 MG Oral TabletSCD89105a78-badb-469e-966e-195fa3a53f0a7
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY89105a78-badb-469e-966e-195fa3a53f0a7
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY89105a78-badb-469e-966e-195fa3a53f0a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1335-0707711335001000 TABLET in 1 BOTTLE (70771-1335-0) 1000 tablet2018-09-130000-00-00NoNoCurrent
70771-1335-27077113350210 in 1 BLISTER PACKHistorical
70771-1335-37077113350330 TABLET in 1 BOTTLE (70771-1335-3) 30 tablet2018-09-130000-00-00NoNoCurrent
70771-1335-47077113350410 BLISTER PACK in 1 CARTON (70771-1335-4) / 10 TABLET in 1 BLISTER PACK (70771-1335-2) 10 blister pack2018-09-130000-00-00NoNoCurrent
70771-1335-870771133508150 TABLET in 1 BOTTLE (70771-1335-8) 150 tablet2018-09-130000-00-00NoNoCurrent