tizanidine hydrochloride

Product NDC
72888-003
11-digit product format
728880003
Labeler code
72888
Product ID
72888-003_3f9bf106-484a-1c3c-e063-6394a90ac8a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA213798
Marketing category
ANDA
Marketing start
2020-05-27
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
2026-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213798-001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-27
A213798-002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-27
A213798-003TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-05-27
A213798-004TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 8MG BASECAPSULE / ORALRS2025-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213798-001AB
A213798-002AB
A213798-003AB

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 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213798-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213798-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213798-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213798-004TIZANIDINE HYDROCHLORIDEEQ 8MG BASECAPSULE / ORALRS2025-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213798-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213798-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213798-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213798-004TIZANIDINE HYDROCHLORIDEEQ 8MG BASECAPSULE / ORALRS2025-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A213798-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213798-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213798-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213798-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213798-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213798-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213798-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213798-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213798-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213798-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213798-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213798-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213798-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213798-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213798-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-05-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213798-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213798-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213798-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-05-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213798-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213798-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213798-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-05-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213798-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A213798-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A213798-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-05-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213798-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213798-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213798-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-05-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213798-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213798-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213798-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-05-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213798-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-05-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213798-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-05-271e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213798-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213798-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213798-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213798-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213798-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213798-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213798-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213798-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213798-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213798-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213798-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213798-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213798-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213798-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213798-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213798-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213798-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213798-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213798-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213798-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213798-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213798-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213798-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213798-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213798-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213798-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213798-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213798-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213798-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213798-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213798-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213798-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213798-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213798-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213798-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213798-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213798-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213798-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213798-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213798-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
tizanidine hydrochloride
Listing expiration
2026-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485484Internal RxNorm lookup
485485Internal RxNorm lookup
485486Internal RxNorm lookup
2723708Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7f39499a-98cf-4d13-9b07-ccb5c22e43c8Available 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
72888-003-15tizanidine hydrochloride150 in 1 BOTTLECAPSULE1505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-003-15EA - Each72888-00371732b27-431c-4c3f-8e65-50f28f028c3812021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-003TIZANIDINE HYDROCHLORIDE CAPSULE [ADVAGEN PHARMA LIMITED]4Current NDC, Legacy NDC, 1 package rows20240729_7f39499a-98cf-4d13-9b07-ccb5c22e43c8.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TizanidineTIZANIDINEDirect_Rx5460dbf8-b30d-db94-e063-6394a90a55532026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213798
application number: ANDA213798
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDETrifluent Pharma, LLC4a2cf456-58c5-c26d-e063-6294a90a0b242026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213798
application number: ANDA213798
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ebccdb33-2b3c-4071-9765-8d95bcbc9b5f2026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213798
application number: ANDA213798
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2c2bdad9-74a5-8508-e063-6294a90aac7f2025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213798
application number: ANDA213798
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEBryant Ranch Prepack9d127a0b-b182-4c8a-91a3-311cc936fd4c2025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213798
application number: ANDA213798
ZanaflexTIZANIDINE HYDROCHLORIDETrifluent Pharma, LLC9833a1b8-f530-4a06-bc77-7d11b6e94c652025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213798
application number: ANDA213798
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEAdvagen Pharma Limited7f39499a-98cf-4d13-9b07-ccb5c22e43c82025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213798
application number: ANDA213798
ndc (product): 72888-003
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d7d5dce0-f8a2-404d-9e87-e2235f5d32682025-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213798
application number: ANDA213798
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e19f83b8-8c59-415c-a744-7473d46ab0ca2025-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213798
application number: ANDA213798
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e94aa8b1-74ed-46b7-94c5-53d5d5630be62025-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213798
application number: ANDA213798
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEBryant Ranch Prepack58c10b87-004e-4d2d-b5c1-b353c2cd071f2025-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213798
application number: ANDA213798

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723708tiZANidine 8 MG Oral CapsulePSN7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485486tiZANidine HCl 2 MG Oral CapsulePSN7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485485tiZANidine HCl 4 MG Oral CapsulePSN7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485484tiZANidine HCl 6 MG Oral CapsulePSN7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485486tizanidine 2 MG Oral CapsuleSCD7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485485tizanidine 4 MG Oral CapsuleSCD7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485484tizanidine 6 MG Oral CapsuleSCD7f39499a-98cf-4d13-9b07-ccb5c22e43c85
2723708tizanidine 8 MG Oral CapsuleSCD7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSY7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY7f39499a-98cf-4d13-9b07-ccb5c22e43c85
2723708tizanidine 8 MG (tizanidine hydrochloride 9.16 MG) Oral CapsuleSY7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485484tiZANidine HCl 6 MG Oral CapsulePSN9d127a0b-b182-4c8a-91a3-311cc936fd4c1
485484tiZANidine HCl 6 MG Oral CapsulePSNe19f83b8-8c59-415c-a744-7473d46ab0ca1
485484tizanidine 6 MG Oral CapsuleSCD9d127a0b-b182-4c8a-91a3-311cc936fd4c1
485484tizanidine 6 MG Oral CapsuleSCDe19f83b8-8c59-415c-a744-7473d46ab0ca1
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY9d127a0b-b182-4c8a-91a3-311cc936fd4c1
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSYe19f83b8-8c59-415c-a744-7473d46ab0ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72888-003-1572888000315150 CAPSULE in 1 BOTTLE (72888-003-15) 150 capsule2020-05-270000-00-00NoNoCurrent