FDA.reportPublic FDA data

TIZANIDINE HYDROCHLORIDE

Product NDC
61919-196
Requested package NDC
61919-196-40
11-digit product format
619190196
Labeler code
61919
Product ID
61919-196_4c484458-33e2-e0cc-e063-6294a90a9e28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIZANIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
TIZANIDINE HYDROCHLORIDE
Application
ANDA091283
Marketing category
ANDA
Marketing start
2014-01-01
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091283-001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28
A091283-002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091283-001AB
A091283-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28a50c72e98297…
2026-08-01 22:54:322026-06A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091283-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091283-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TizanidineTIZANIDINENuCare Pharmaceuticals,Inc.6dd9946f-b2a4-1732-e053-2a91aa0a648f2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEREMEDYREPACK INC.b14bd166-9f53-4f2e-be05-c447af04ef692026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE047c67cd-7a63-49c9-b100-71651d3537ba2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
ndc (package): 61919-196-40
ndc (product): 61919-196
ndc11 (package): 61919019640
TIZANDINETIZANDINEDirect_Rx9003cb5d-f9d6-7183-e053-2995a90ad6e82026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEA-S Medication Solutions308d2fdc-6136-4e75-95d3-342497add66c2026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEA-S Medication Solutions9fd932fb-033c-4774-ac09-c823db8f97392026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINERedpharm Drug49adcfc8-3b1d-7f7e-e063-6294a90a361e2026-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEPD-Rx Pharmaceuticals, Inc.615dfd5c-125a-40e2-a6da-afacde3052822025-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEUnichem Pharmaceuticals (USA), Inc.a3fa9c69-4baf-44f5-bac4-a19c34b0e1cb2025-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEA-S Medication Solutions9678a98e-4aab-4d87-b5e1-37c3109e378e2025-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEBryant Ranch Prepackf87e30ce-a60a-41e3-b5d6-7e29661439612025-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEPreferred Pharmaceuticals Inc.6e97c1ba-8171-4707-98ee-61afed75daac2025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
Tizanidine HCLTIZANIDINE HCLAdvanced Rx of Tennessee, LLCafc96ee6-c99b-7283-e053-2a95a90ad14d2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEAdvanced Rx Pharmacy of Tennessee, LLCd2961d1c-5de2-0a2b-e053-2995a90ad2fc2024-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEProficient Rx LPe13b111a-25b7-4fdd-a102-30f2996722f32024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEProficient Rx LP5b7b4721-e6fa-4586-ac40-091ad363ee852022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEAphena Pharma Solutions - Tennessee, LLCea242c7d-b101-4197-8e65-b2b079e3b2b62019-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283

Additional Listing Data#

Finished product
Yes
Brand name base
TIZANIDINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B53E3NMY5CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313413Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
047c67cd-7a63-49c9-b100-71651d3537baAvailable on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-196-302025-01-30C16284748780-12cef2736-8331-d83d-e063-dadaa90ab31fTIZANIDINE HYDROCHLORIDE
61919-196-402025-01-30C16284748780-12cef2736-8331-d83d-e063-dadaa90ab31fTIZANIDINE HYDROCHLORIDE
61919-196-602025-01-30C16284748780-12cef2736-8331-d83d-e063-dadaa90ab31fTIZANIDINE HYDROCHLORIDE
61919-196-722025-01-30C16284748780-12cef2736-8331-d83d-e063-dadaa90ab31fTIZANIDINE HYDROCHLORIDE
61919-196-902025-01-30C16284748780-12cef2736-8331-d83d-e063-dadaa90ab31fTIZANIDINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-196-20TIZANIDINE HYDROCHLORIDE20 in 1 BOTTLETABLET207
61919-196-30TIZANIDINE HYDROCHLORIDE30 in 1 BOTTLETABLET307
61919-196-40TIZANIDINE HYDROCHLORIDE40 in 1 BOTTLETABLET407
61919-196-60TIZANIDINE HYDROCHLORIDE60 in 1 BOTTLETABLET607
61919-196-72TIZANIDINE HYDROCHLORIDE72 in 1 BOTTLETABLET727
61919-196-90TIZANIDINE HYDROCHLORIDE90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-196-30EA - Each61919-196d9738507-dea3-4be7-b22f-54f870b4281512015-04-03
61919-196-40EA - Each61919-196531d7162-f55a-4f54-97fb-dc6d3a53d61712021-07-15
61919-196-60EA - Each61919-1963c5664c8-e3b7-49a1-b452-6250761e780c12015-04-03
61919-196-72EA - Each61919-196398afc75-eec5-4737-90e2-35b0d20222cb12015-04-03
61919-196-90EA - Each61919-1963e8bbb6b-c8c9-4c8b-81ef-dd2fc12dc44212015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]1
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-196TIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]6Current NDC, Legacy NDC, 6 package rows20230413_047c67cd-7a63-49c9-b100-71651d3537ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN047c67cd-7a63-49c9-b100-71651d3537ba7
313413tizanidine 4 MG Oral TabletSCD047c67cd-7a63-49c9-b100-71651d3537ba7
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY047c67cd-7a63-49c9-b100-71651d3537ba7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-196-406191901964040 TABLET in 1 BOTTLE (61919-196-40) 40 tablet2014-01-010000-00-00NoNoCurrent