Home NDC 83107-004 Zanaflex
Product NDC 83107-004
11-digit product format 831070004
Labeler code 83107
Product ID 83107-004_476ae6e6-0732-af36-e063-6394a90a7c02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tizanidine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Legacy Pharma USA, Inc.
Application NDA020397
Marketing category NDA
Marketing start 2018-08-01
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 43 .
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 N020397-001 ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 N020397-002 ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020397-001 AB
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 · 86 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 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020397-002 ZANAFLEX EQ 2MG BASE TABLET / ORAL RLD 2000-02-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020397-002 ZANAFLEX EQ 2MG BASE TABLET / ORAL RLD 2000-02-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020397-002 ZANAFLEX EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 2000-02-04 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 Zanaflex
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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 153735 Internal RxNorm lookup 313413 Internal RxNorm lookup 485484 Internal RxNorm lookup 485485 Internal RxNorm lookup 485486 Internal RxNorm lookup 580267 Internal RxNorm lookup 583165 Internal RxNorm lookup 583211 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 83107-004-15 Zanaflex 150 in 1 BOTTLE TABLET 150 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83107-004 ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [LEGACY PHARMA USA, INC.] 1 Current NDC, 1 package rows 20241206_60c27d35-7349-4fc6-86ad-70fffdbe3e08.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 Sample Exclude flag Status 83107-004-15 83107000415 150 TABLET in 1 BOTTLE (83107-004-15) 150 tablet 2018-08-01 No No Current