Home NDC 55289-612 Zanaflex
Product NDC 55289-612
11-digit product format 552890612
Labeler code 55289
Product ID 55289-612_a6bb7fe3-86e5-4834-e053-2995a90a1541
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tizanidine hydrochloride
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA020397
Marketing category NDA
Marketing start 1997-01-01
Marketing end 2020-09-30
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 0000-00-00
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-02-04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 · 84 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 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…2022-03-09 01:35 UTC 2022-03 N020397-001 ZANAFLEX EQ 4MG BASE TABLET / ORAL AB RLD, RS 1996-11-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 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 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# 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.