Home NDC 46708-493 Tizanidine Hydrochloride
Product NDC 46708-493
11-digit product format 467080493
Labeler code 46708
Product ID 46708-493_cf7c5bb7-d94b-4c98-a4a2-e6a917e4165b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tizanidine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA213223
Marketing category ANDA
Marketing start 2020-01-15
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 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 A213223-001 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 A213223-002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 A213223-003 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13
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 3 · 114 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 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213223-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213223-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213223-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213223-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213223-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213223-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213223-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213223-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213223-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213223-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213223-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213223-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213223-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213223-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213223-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213223-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213223-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213223-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213223-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213223-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213223-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213223-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213223-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213223-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213223-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2020-01-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213223-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2020-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213223-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2020-01-13 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 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 6 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 46708-493-08 2023-02-01 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 46708-493-30 2023-02-01 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 46708-493-41 2023-02-01 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 46708-493-91 2023-02-01 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 46708-493-08 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 46708-493-30 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 46708-493-41 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 46708-493-91 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-493-08 Tizanidine Hydrochloride 8 in 1 BLISTER PACK CAPSULE 8 2 46708-493-08 Tizanidine Hydrochloride 80 in 1 CARTON CAPSULE 80 2 46708-493-30 Tizanidine Hydrochloride 30 in 1 BOTTLE CAPSULE 30 2 46708-493-41 Tizanidine Hydrochloride 150 in 1 BOTTLE CAPSULE 150 2 46708-493-91 Tizanidine Hydrochloride 1000 in 1 BOTTLE CAPSULE 1000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-493 TIZANIDINE HYDROCHLORIDE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] 2 Current NDC, Legacy NDC, 5 package rows 20230202_29750221-497e-4747-a9b8-12a0c2236eae.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 Units Marketing start Marketing end Sample Exclude flag Status 46708-493-08 46708049308 80 BLISTER PACK in 1 CARTON (46708-493-08) / 8 CAPSULE in 1 BLISTER PACK 80 blister pack 2020-01-15 0000-00-00 No No Current 46708-493-30 46708049330 30 CAPSULE in 1 BOTTLE (46708-493-30) 30 capsule 2020-01-15 0000-00-00 No No Current 46708-493-41 46708049341 150 CAPSULE in 1 BOTTLE (46708-493-41) 150 capsule 2020-01-15 0000-00-00 No No Current 46708-493-91 46708049391 1000 CAPSULE in 1 BOTTLE (46708-493-91) 1000 capsule 2020-01-15 0000-00-00 No No Current