Home NDC 60505-2648 Tizanidine Hydrochloride
Product NDC 60505-2648
11-digit product format 605052648
Labeler code 60505
Product ID 60505-2648_f68c762c-26fc-7c61-1a94-6b5110937eea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tizanidine Hydrochloride
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Apotex Corp.
Application ANDA078868
Marketing category ANDA
Marketing start 2012-02-06
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078868-001 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 A078868-002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 A078868-003 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 2026-08-18 06:07:40 2026-07 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tizanidine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIZANIDINE HYDROCHLORIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B53E3NMY5C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485484 Internal RxNorm lookup 485485 Internal RxNorm lookup 485486 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-2648-0 Tizanidine Hydrochloride 10 in 1 CARTON CAPSULE, GELATIN COATED 10 12 60505-2648-0 Tizanidine Hydrochloride 10 in 1 BLISTER PACK CAPSULE, GELATIN COATED 10 12 60505-2648-3 Tizanidine Hydrochloride 30 in 1 BOTTLE CAPSULE, GELATIN COATED 30 12 60505-2648-7 Tizanidine Hydrochloride 150 in 1 BOTTLE CAPSULE, GELATIN COATED 150 12 60505-2648-8 Tizanidine Hydrochloride 1000 in 1 BOTTLE CAPSULE, GELATIN COATED 1000 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TIZANIDINE HYDROCHLORIDE ACTIVE INGREDIENT B53E3NMY5C TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 TIZANIDINE ACTIVE MOIETY 6AI06C00GW TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 POLYVINYL ACETATE PHTHALATE INACTIVE INGREDIENT 58QVG85GW3 TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 3 TIZANIDINE HYDROCHLORIDE ACTIVE INGREDIENT B53E3NMY5C TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 TIZANIDINE ACTIVE MOIETY 6AI06C00GW TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 POLYVINYL ACETATE PHTHALATE INACTIVE INGREDIENT 58QVG85GW3 TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-2648 TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.] 11 Current NDC, Legacy NDC, 5 package rows 20241224_3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-2648-0 60505264800 10 in 1 CARTON Historical 60505-2648-3 60505264803 30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2648-3) 2012-02-06 0000-00-00 No No Current 60505-2648-7 60505264807 150 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2648-7) 2012-02-06 0000-00-00 No No Current 60505-2648-8 60505264808 1000 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2648-8) 2012-02-06 0000-00-00 No No Current