Home NDC 60505-0252-2 tizanidine
Product NDC 60505-0252
Requested package NDC 60505-0252-2
11-digit product format 605050252
Labeler code 60505
Product ID 60505-0252_4bf9e490-aaca-0e56-d17d-9f513e09f552
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tizanidine
Dosage form TABLET
Route ORAL
Labeler Apotex Corp.
Application ANDA076533
Marketing category ANDA
Marketing start 2004-01-16
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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076533-001 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 A076533-002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076533-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2004-01-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076533-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2004-01-16 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base tizanidine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIZANIDINE HYDROCHLORIDE 4 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-0252-1 tizanidine 100 in 1 BOTTLE TABLET 100 14 60505-0252-2 tizanidine 1000 in 1 BOTTLE TABLET 1000 14 60505-0252-3 tizanidine 150 in 1 BOTTLE TABLET 150 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Tizanidine Hydrochloride ACTIVE INGREDIENT B53E3NMY5C TIZANIDINE TABLET [APOTEX CORP.] 5 Tizanidine ACTIVE MOIETY 6AI06C00GW TIZANIDINE TABLET [APOTEX CORP.] 5 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK TIZANIDINE TABLET [APOTEX CORP.] 5 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TIZANIDINE TABLET [APOTEX CORP.] 5 colloidal silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 TIZANIDINE TABLET [APOTEX CORP.] 5 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP TIZANIDINE TABLET [APOTEX CORP.] 5 tizanidine hydrochloride ACTIVE INGREDIENT B53E3NMY5C TIZANIDINE TABLET [PROFICIENT RX LP] 3 Tizanidine ACTIVE MOIETY 6AI06C00GW TIZANIDINE TABLET [PROFICIENT RX LP] 3 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK TIZANIDINE TABLET [PROFICIENT RX LP] 3 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TIZANIDINE TABLET [PROFICIENT RX LP] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TIZANIDINE TABLET [PROFICIENT RX LP] 3 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP TIZANIDINE TABLET [PROFICIENT RX LP] 3 TIZANIDINE HYDROCHLORIDE ACTIVE INGREDIENT B53E3NMY5C TIZANIDINE TABLET [MAJOR PHARMACEUTICALS] 2 Tizanidine Hydrochloride ACTIVE INGREDIENT B53E3NMY5C TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 Tizanidine Hydrochloride ACTIVE INGREDIENT B53E3NMY5C TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.] 2 TIZANIDINE HYDROCHLORIDE ACTIVE INGREDIENT B53E3NMY5C TIZANIDINE TABLET [DIRECT RX] 2 TIZANIDINE ACTIVE MOIETY 6AI06C00GW TIZANIDINE TABLET [DIRECT RX] 2 Tizanidine ACTIVE MOIETY 6AI06C00GW TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.] 2 Tizanidine ACTIVE MOIETY 6AI06C00GW TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 TIZANIDINE ACTIVE MOIETY 6AI06C00GW TIZANIDINE TABLET [MAJOR PHARMACEUTICALS] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TIZANIDINE TABLET [MAJOR PHARMACEUTICALS] 2 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TIZANIDINE TABLET [DIRECT RX] 2 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TIZANIDINE TABLET [MAJOR PHARMACEUTICALS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TIZANIDINE TABLET [DIRECT RX] 2 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TIZANIDINE TABLET [DIRECT RX] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TIZANIDINE TABLET [MAJOR PHARMACEUTICALS] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TIZANIDINE TABLET [MAJOR PHARMACEUTICALS] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TIZANIDINE TABLET [DIRECT RX] 2 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.] 2 tizanidine hydrochloride ACTIVE INGREDIENT B53E3NMY5C TIZANIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 Tizanidine ACTIVE MOIETY 6AI06C00GW TIZANIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK TIZANIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TIZANIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TIZANIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP TIZANIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-0252 TIZANIDINE TABLET [APOTEX CORP.] 14 Current NDC, Legacy NDC, 3 package rows 20250313_01c0d3d3-2373-a1b7-822a-80a66291a248.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60505-0252-2 60505025202 1000 TABLET in 1 BOTTLE (60505-0252-2) 1000 tablet 2004-01-16 0000-00-00 No No Current