Home NDC 59746-672-05 Tizanidine Hydrochloride
Product NDC 59746-672
Requested package NDC 59746-672-05
11-digit product format 597460672
Labeler code 59746
Product ID 59746-672_b384b1a9-6301-4d3f-a6f1-4deb5f58e6e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tizanidine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Jubilant Cadista Pharmaceuticals Inc.
Application ANDA209605
Marketing category ANDA
Marketing start 2017-08-04
Marketing end 0000-00-00
Substance TIZANIDINE
Active strength 6 mg/1
Pharmacologic classes Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209605-001 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 A209605-002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 A209605-003 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209605-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209605-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209605-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209605-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209605-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209605-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209605-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209605-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209605-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209605-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209605-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209605-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209605-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209605-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209605-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209605-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209605-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209605-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209605-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209605-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209605-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209605-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209605-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209605-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209605-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-08-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209605-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-08-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209605-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-08-04 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 59746-672-01 2025-12-31 These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996 59746-672-05 2025-12-31 These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996 59746-672-30 2025-12-31 These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996 59746-672-34 2025-12-31 These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996 59746-672-01 2023-01-30 These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996 59746-672-05 2023-01-30 These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996 59746-672-30 2023-01-30 These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996 59746-672-34 2023-01-30 These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59746-672 TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.] 3 Legacy NDC 20170811_e803d28e-0610-a52c-3295-dd2d148531aa.zip
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 59746-672-05 59746067205 500 CAPSULE in 1 BOTTLE (59746-672-05) 500 capsule 2017-08-04 0000-00-00 No No Current