Home NDC 84386-024-77 TIZANIDINE
Product NDC 84386-024
Requested package NDC 84386-024-77
11-digit product format 843860024
Labeler code 84386
Product ID 84386-024_7ce17c02-7f1f-4d52-8b6f-52e385e12239
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TIZANIDINE
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA076282
Marketing category ANDA
Marketing start 2026-09-01
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 44 .
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 A076282-001 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-12-16 A076282-002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-12-16
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 · 88 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 2026-10-15 13:18:30 2026-09 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-12-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-12-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076282-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2003-12-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076282-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2003-12-16 4b0b4de00fa7…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-10-15 13:18:30 2026-09 A076282-001 AB 1 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076282-002 AB 1 c2088c7a36db…
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
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313412 Internal RxNorm lookup 313413 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84386-024-77 84386002477 150 TABLET in 1 BOTTLE (84386-024-77) 150 tablet 2026-09-01 No No Current