Tizanidne hydrochloride

Product NDC
71335-2210
Requested package NDC
71335-2210-1
11-digit product format
713352210
Labeler code
71335
Product ID
71335-2210_657b341b-ea3e-487c-9b7f-de84dd63c98e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidne Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212196
Marketing category
ANDA
Marketing start
2019-03-29
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
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212196-001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27
A212196-002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27
A212196-003TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A212196-001AB
A212196-002AB
A212196-003AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212196-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212196-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212196-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212196-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212196-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212196-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212196-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212196-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212196-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212196-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212196-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212196-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212196-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212196-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212196-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212196-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212196-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212196-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212196-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212196-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212196-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212196-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212196-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212196-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212196-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212196-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212196-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212196-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212196-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212196-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212196-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212196-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212196-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212196-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212196-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212196-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212196-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212196-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212196-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212196-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidne hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE6 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
485484Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4fd5b1b8-ec86-42c2-9065-aee581f1bdd6Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2210-1Tizanidne hydrochloride150 in 1 BOTTLECAPSULE150101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2210-1EA - Each71335-22107cb42693-2a2e-4331-9a00-2979883ee14612023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2210TIZANIDNE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20230805_4fd5b1b8-ec86-42c2-9065-aee581f1bdd6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack649f1f76-da33-4bdf-a38d-5ae3a9cb79872026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack70b1a815-8549-4602-af35-fdbedf5fad512026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack4fd5b1b8-ec86-42c2-9065-aee581f1bdd62026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
ndc (package): 71335-2210-1
ndc (product): 71335-2210
ndc11 (package): 71335221001
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack226b506f-6f85-48e8-b8e5-86442d74d9512026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack31b40276-099b-482c-a13c-8fbbf1ebc50a2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack04febb37-00d6-4279-8c5f-171950278c8f2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack3288d98d-aa49-4a36-a6d9-703645d8bcd72026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEPreferred Pharmaceuticals Inc.3f569c5a-ec9d-4356-ac04-c17714ff68d12026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEAscend Laboratories, LLCd7c97b79-da59-4e86-a01b-f91046d04f742025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDEAsclemed USA, Inc.07b8db58-d037-477e-a62f-025e8a5afcb42025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidine HCLTIZANIDINE HCLAdvanced Rx Pharmacy of Tennessee, LLCc46c7aa3-69db-82dc-e053-2995a90ac2512025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack00fcd792-18a4-45d9-9c6e-0634b54b152a2024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepacka4233306-2954-496f-9686-22c48041710d2024-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack30df9966-5076-449f-867b-28cb9b8356932024-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEAsclemed USA, Inc.1ad6eaf6-bd32-4d05-bdd0-a6246e2afb9c2022-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485484tiZANidine HCl 6 MG Oral CapsulePSN4fd5b1b8-ec86-42c2-9065-aee581f1bdd6101
485484tizanidine 6 MG Oral CapsuleSCD4fd5b1b8-ec86-42c2-9065-aee581f1bdd6101
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY4fd5b1b8-ec86-42c2-9065-aee581f1bdd6101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2210-171335221001150 CAPSULE in 1 BOTTLE (71335-2210-1) 150 capsule2023-08-04NoNoCurrent