Tizanidine

Product NDC
55111-179
11-digit product format
551110179
Labeler code
55111
Product ID
55111-179_386ec98d-4a47-b025-b050-7e4ebce382c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA076286
Marketing category
ANDA
Marketing start
2002-07-03
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

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
A076286-001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03
A076286-002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076286-001AB
A076286-002AB

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03782e0a99824c…
2021-12-28 21:50 UTC2021-12A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076286-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076286-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076286-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076286-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076286-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076286-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076286-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076286-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076286-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076286-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076286-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076286-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076286-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076286-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076286-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076286-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076286-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076286-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076286-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076286-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076286-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076286-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076286-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076286-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076286-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076286-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076286-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076286-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076286-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076286-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076286-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076286-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076286-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076286-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076286-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076286-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076286-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076286-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076286-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076286-002AB1782e0a99824c…

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 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313412Internal RxNorm lookup
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
a42f3479-f2c2-8214-d547-c5cae9bfed1eAvailable 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
55111-179-03Tizanidine300 in 1 BOTTLETABLET30015
55111-179-10Tizanidine1000 in 1 BOTTLETABLET100015
55111-179-15Tizanidine150 in 1 BOTTLETABLET15015
55111-179-30Tizanidine30 in 1 BOTTLETABLET3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-179-10EA - Each55111-1791430cb1b-2325-4820-8454-6c96c6ed65a912012-07-24
55111-179-15EA - Each55111-179b263aa3c-5366-4a95-a1ee-c917a75f895812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964
tizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]9
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]9
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]9
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]9
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]9
stearic acidINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]9
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]4
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]4
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [H.J. HARKINS COMPANY, INC.]3
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [H.J. HARKINS COMPANY, INC.]3
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC]2
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [STAT RX USA LLC]2
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [MEDSOURCE PHARMACEUTICALS]2
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [UNIT DOSE SERVICES]2
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [STAT RX USA LLC]2
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [UNIT DOSE SERVICES]2
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC]2
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [MEDSOURCE PHARMACEUTICALS]2
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [UNIT DOSE SERVICES]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [STAT RX USA LLC]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [MEDSOURCE PHARMACEUTICALS]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [STAT RX USA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [MEDSOURCE PHARMACEUTICALS]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [UNIT DOSE SERVICES]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [MEDSOURCE PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [STAT RX USA LLC]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [STAT RX USA LLC]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [UNIT DOSE SERVICES]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [MEDSOURCE PHARMACEUTICALS]2
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [ALTURA PHARMACEUTICALS, INC.]1
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [BRYANT RANCH PREPACK]1
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [BRYANT RANCH PREPACK]1
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [ALTURA PHARMACEUTICALS, INC.]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [BRYANT RANCH PREPACK]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [ALTURA PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [ALTURA PHARMACEUTICALS, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [BRYANT RANCH PREPACK]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [BRYANT RANCH PREPACK]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [ALTURA PHARMACEUTICALS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [ALTURA PHARMACEUTICALS, INC.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [BRYANT RANCH PREPACK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-179TIZANIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]13Current NDC, Legacy NDC, 4 package rows20200902_a42f3479-f2c2-8214-d547-c5cae9bfed1e.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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TizanidineTIZANIDINEHAWAII REPACK, INC.45de30ce-959f-4e2e-a974-6f90568139c92026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEREMEDYREPACK INC.59084f59-9a9b-49f0-a9f4-27f3eab9a2282026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINERedpharm Drug54ade0c7-4bf0-54d4-e063-6294a90a8b172026-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINESt. Mary's Medical Park Pharmacyc6b4486f-e847-64ee-e053-2995a90a855a2026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINESt. Mary's Medical Park Pharmacycfd52c0c-a7c2-e23d-e053-2a95a90abbd12026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEREMEDYREPACK INC.9bcc7f09-d2b5-4602-aaf3-5410b55ce2752026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEREMEDYREPACK INC.7bbc81e5-ad3e-496b-908f-e6f500f6ad7e2026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEDirect_rx29a275f9-de6b-ee63-e063-6294a90aba282026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEAvPAKb694225c-1fa9-4726-89a6-fd3f870842482026-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEPD-Rx Pharmaceuticals, Inc.ac897a5a-677b-4a6e-abb1-b810470200fc2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINENorthwind Health Company, LLCda31fbeb-3781-5e75-e053-2a95a90adb732026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
Tizanidine HClTIZANIDINE HCLAdvanced Rx Pharmacy of Tennessee, LLCafc90292-c6bf-2d96-e053-2995a90abf002025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEPreferred Pharmaceuticals Inc.3c993e3c-ee52-45a7-be39-60eaac7a10922025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEPreferred Pharmaceuticals, Inc.32c3be66-5398-425c-ac65-e57ba819bb432025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEAsclemed USA, Inc.24d8b33f-d1fb-4b4a-afbe-e2e7134dce292025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEPHOENIX RX LLC3a7b9b9a-9bf9-0b37-e063-6294a90a1c392025-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEAmerican Health Packaging3670f9e3-988d-48e6-9df0-d403d699e08a2025-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEA-S Medication Solutions180985f0-3fbd-4868-a826-b84101618a032025-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINENuCare Pharmaceuticals,Inc.fe2f5064-0b7c-d03d-e053-6294a90a96042025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEProficient Rx LPc2353d09-3cb4-486e-8ae7-29339c1ba76b2025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSNb68a9f81-7138-48cf-b987-b8d284e8105a3973
313412tizanidine 2 MG Oral TabletSCDb68a9f81-7138-48cf-b987-b8d284e8105a3973
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYb68a9f81-7138-48cf-b987-b8d284e8105a3973
313412tiZANidine HCl 2 MG Oral TabletPSN180985f0-3fbd-4868-a826-b84101618a0328
313413tiZANidine HCl 4 MG Oral TabletPSN180985f0-3fbd-4868-a826-b84101618a0328
313412tizanidine 2 MG Oral TabletSCD180985f0-3fbd-4868-a826-b84101618a0328
313413tizanidine 4 MG Oral TabletSCD180985f0-3fbd-4868-a826-b84101618a0328
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY180985f0-3fbd-4868-a826-b84101618a0328
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY180985f0-3fbd-4868-a826-b84101618a0328
313412tiZANidine HCl 2 MG Oral TabletPSNa42f3479-f2c2-8214-d547-c5cae9bfed1e15
313413tiZANidine HCl 4 MG Oral TabletPSNa42f3479-f2c2-8214-d547-c5cae9bfed1e15
313412tizanidine 2 MG Oral TabletSCDa42f3479-f2c2-8214-d547-c5cae9bfed1e15
313413tizanidine 4 MG Oral TabletSCDa42f3479-f2c2-8214-d547-c5cae9bfed1e15
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYa42f3479-f2c2-8214-d547-c5cae9bfed1e15
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYa42f3479-f2c2-8214-d547-c5cae9bfed1e15
313412tiZANidine HCl 2 MG Oral TabletPSN3670f9e3-988d-48e6-9df0-d403d699e08a12
313413tiZANidine HCl 4 MG Oral TabletPSN3670f9e3-988d-48e6-9df0-d403d699e08a12
313412tizanidine 2 MG Oral TabletSCD3670f9e3-988d-48e6-9df0-d403d699e08a12
313413tizanidine 4 MG Oral TabletSCD3670f9e3-988d-48e6-9df0-d403d699e08a12
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY3670f9e3-988d-48e6-9df0-d403d699e08a12
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY3670f9e3-988d-48e6-9df0-d403d699e08a12
313412tiZANidine HCl 2 MG Oral TabletPSNafc90292-c6bf-2d96-e053-2995a90abf009
313413tiZANidine HCl 4 MG Oral TabletPSNafc90292-c6bf-2d96-e053-2995a90abf009
313412tizanidine 2 MG Oral TabletSCDafc90292-c6bf-2d96-e053-2995a90abf009
313413tizanidine 4 MG Oral TabletSCDafc90292-c6bf-2d96-e053-2995a90abf009
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYafc90292-c6bf-2d96-e053-2995a90abf009
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYafc90292-c6bf-2d96-e053-2995a90abf009
313412tiZANidine HCl 2 MG Oral TabletPSN988cbeae-64ed-4ce1-b503-f5e7b77f1a2a7
313412tizanidine 2 MG Oral TabletSCD988cbeae-64ed-4ce1-b503-f5e7b77f1a2a7
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY988cbeae-64ed-4ce1-b503-f5e7b77f1a2a7
313412tiZANidine HCl 2 MG Oral TabletPSNb694225c-1fa9-4726-89a6-fd3f870842486
313412tiZANidine HCl 2 MG Oral TabletPSN7bbc81e5-ad3e-496b-908f-e6f500f6ad7e6
313413tiZANidine HCl 4 MG Oral TabletPSNb694225c-1fa9-4726-89a6-fd3f870842486
313412tizanidine 2 MG Oral TabletSCD7bbc81e5-ad3e-496b-908f-e6f500f6ad7e6
313412tizanidine 2 MG Oral TabletSCDb694225c-1fa9-4726-89a6-fd3f870842486
313413tizanidine 4 MG Oral TabletSCDb694225c-1fa9-4726-89a6-fd3f870842486
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY7bbc81e5-ad3e-496b-908f-e6f500f6ad7e6
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYb694225c-1fa9-4726-89a6-fd3f870842486
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYb694225c-1fa9-4726-89a6-fd3f870842486
313412tiZANidine HCl 2 MG Oral TabletPSN24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313412tiZANidine HCl 2 MG Oral TabletPSN3c993e3c-ee52-45a7-be39-60eaac7a10925
313413tiZANidine HCl 4 MG Oral TabletPSN24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313412tizanidine 2 MG Oral TabletSCD24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313412tizanidine 2 MG Oral TabletSCD3c993e3c-ee52-45a7-be39-60eaac7a10925
313413tizanidine 4 MG Oral TabletSCD24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY3c993e3c-ee52-45a7-be39-60eaac7a10925
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313412tiZANidine HCl 2 MG Oral TabletPSN29a275f9-de6b-ee63-e063-6294a90aba284
313412tiZANidine HCl 2 MG Oral TabletPSN82084f4e-00d0-c298-c13a-88a6c0860b024
313412tizanidine 2 MG Oral TabletSCD29a275f9-de6b-ee63-e063-6294a90aba284
313412tizanidine 2 MG Oral TabletSCD82084f4e-00d0-c298-c13a-88a6c0860b024
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY82084f4e-00d0-c298-c13a-88a6c0860b024
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY29a275f9-de6b-ee63-e063-6294a90aba284
313412tiZANidine HCl 2 MG Oral TabletPSN6d8e0262-5ccf-4447-90dd-f5eec069664c3
313412tiZANidine HCl 2 MG Oral TabletPSNcfd52c0c-a7c2-e23d-e053-2a95a90abbd13
313412tiZANidine HCl 2 MG Oral TabletPSNde99d950-9f01-9451-e053-2a95a90a9ec53
313412tiZANidine HCl 2 MG Oral TabletPSN9d222859-6697-47bf-98ec-91984002e0d93
313413tiZANidine HCl 4 MG Oral TabletPSN9d222859-6697-47bf-98ec-91984002e0d93
313413tiZANidine HCl 4 MG Oral TabletPSN6d8e0262-5ccf-4447-90dd-f5eec069664c3
313412tizanidine 2 MG Oral TabletSCD9d222859-6697-47bf-98ec-91984002e0d93
313412tizanidine 2 MG Oral TabletSCDcfd52c0c-a7c2-e23d-e053-2a95a90abbd13
313412tizanidine 2 MG Oral TabletSCDde99d950-9f01-9451-e053-2a95a90a9ec53
313412tizanidine 2 MG Oral TabletSCD6d8e0262-5ccf-4447-90dd-f5eec069664c3
313413tizanidine 4 MG Oral TabletSCD9d222859-6697-47bf-98ec-91984002e0d93
313413tizanidine 4 MG Oral TabletSCD6d8e0262-5ccf-4447-90dd-f5eec069664c3
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY9d222859-6697-47bf-98ec-91984002e0d93
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYcfd52c0c-a7c2-e23d-e053-2a95a90abbd13
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYde99d950-9f01-9451-e053-2a95a90a9ec53
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY6d8e0262-5ccf-4447-90dd-f5eec069664c3
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY9d222859-6697-47bf-98ec-91984002e0d93
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY6d8e0262-5ccf-4447-90dd-f5eec069664c3
313412tiZANidine HCl 2 MG Oral TabletPSNfe2f5064-0b7c-d03d-e053-6294a90a96042
313412tiZANidine HCl 2 MG Oral TabletPSN5a42267f-a400-4bfd-ad7c-fad335884ba82
313412tiZANidine HCl 2 MG Oral TabletPSNa204c899-a892-41db-a96b-45478e5588f22
313412tiZANidine HCl 2 MG Oral TabletPSN9852284f-0101-4167-81d5-e74732b95e8f2
313413tiZANidine HCl 4 MG Oral TabletPSNa204c899-a892-41db-a96b-45478e5588f22
313413tiZANidine HCl 4 MG Oral TabletPSN9852284f-0101-4167-81d5-e74732b95e8f2
313412tizanidine 2 MG Oral TabletSCDa204c899-a892-41db-a96b-45478e5588f22
313412tizanidine 2 MG Oral TabletSCD5a42267f-a400-4bfd-ad7c-fad335884ba82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-179-0355111017903300 TABLET in 1 BOTTLE (55111-179-03) 300 tablet2002-07-030000-00-00NoNoCurrent
55111-179-10551110179101000 TABLET in 1 BOTTLE (55111-179-10) 1000 tablet2002-07-030000-00-00NoNoCurrent
55111-179-1555111017915150 TABLET in 1 BOTTLE (55111-179-15) 150 tablet2002-07-030000-00-00NoNoCurrent
55111-179-305511101793030 TABLET in 1 BOTTLE (55111-179-30) 30 tablet2002-07-030000-00-00NoNoCurrent