Home NDC 70771-1067-5 tizanidine hydrochloride
Product NDC 70771-1067
Requested package NDC 70771-1067-5
11-digit product format 707711067
Labeler code 70771
Product ID 70771-1067_e5aa06ec-9ceb-4c1c-9334-90bef0d9366f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tizanidine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA208622
Marketing category ANDA
Marketing start 2017-04-27
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 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208622-001 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 A208622-002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 A208622-003 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03
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 · 129 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 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208622-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208622-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208622-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208622-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208622-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208622-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208622-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208622-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208622-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208622-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208622-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208622-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208622-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208622-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208622-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208622-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208622-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208622-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208622-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208622-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208622-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208622-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208622-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208622-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208622-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2017-03-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208622-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2017-03-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208622-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2017-03-03 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 hydrochloride
Listing expiration 2027-12-31 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 70771-1067-4 tizanidine hydrochloride 10 in 1 CARTON CAPSULE 10 8 70771-1067-4 tizanidine hydrochloride 10 in 1 BLISTER PACK CAPSULE 10 8 70771-1067-5 tizanidine hydrochloride 500 in 1 BOTTLE CAPSULE 500 8 70771-1067-8 tizanidine hydrochloride 150 in 1 BOTTLE CAPSULE 150 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1067 TIZANIDINE HYDROCHLORIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED] 6 Current NDC, Legacy NDC, 4 package rows 20241210_5f4889d1-1387-4c90-9b76-00beda3c1683.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 70771-1067-5 70771106705 500 CAPSULE in 1 BOTTLE (70771-1067-5) 500 capsule 2017-04-27 0000-00-00 No No Current