Home NDC 55289-784 tizanidine hydrochloride
Product NDC 55289-784
11-digit product format 552890784
Labeler code 55289
Product ID 55289-784_e9abb2df-0b93-3850-e053-2a95a90abc7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tizanidine hydrochloride
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA076280
Marketing category ANDA
Marketing start 2002-06-27
Marketing end 2022-09-30
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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A076280-001 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 A076280-002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2002-11-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2002-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2002-11-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2002-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2002-11-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2002-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2002-11-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2002-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2002-11-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2002-06-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2002-11-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2002-06-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TIZANIDINE HYDROCHLORIDE ACTIVE INGREDIENT B53E3NMY5C TIZANIDINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 13 TIZANIDINE ACTIVE MOIETY 6AI06C00GW TIZANIDINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TIZANIDINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 13 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TIZANIDINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 13 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TIZANIDINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 13 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TIZANIDINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 13 TIZANIDINE HYDROCHLORIDE ACTIVE INGREDIENT B53E3NMY5C COMFORT PAC WITH TIZANIDINE (TIZANIDINE) KIT [PD-RX PHARMACEUTICALS, INC.] 1 TIZANIDINE ACTIVE MOIETY 6AI06C00GW COMFORT PAC WITH TIZANIDINE (TIZANIDINE) KIT [PD-RX PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COMFORT PAC WITH TIZANIDINE (TIZANIDINE) KIT [PD-RX PHARMACEUTICALS, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X COMFORT PAC WITH TIZANIDINE (TIZANIDINE) KIT [PD-RX PHARMACEUTICALS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COMFORT PAC WITH TIZANIDINE (TIZANIDINE) KIT [PD-RX PHARMACEUTICALS, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP COMFORT PAC WITH TIZANIDINE (TIZANIDINE) KIT [PD-RX PHARMACEUTICALS, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-784-20 55289078420 20 TABLET in 1 BOTTLE, PLASTIC (55289-784-20) 20 tablet 2004-04-16 0000-00-00 No No Current 55289-784-30 55289078430 30 TABLET in 1 BOTTLE, PLASTIC (55289-784-30) 30 tablet 2007-06-20 0000-00-00 No No Current 55289-784-60 55289078460 60 TABLET in 1 BOTTLE, PLASTIC (55289-784-60) 60 tablet 2006-03-08 0000-00-00 No No Current 55289-784-90 55289078490 90 TABLET in 1 BOTTLE, PLASTIC (55289-784-90) 90 tablet 2007-11-13 0000-00-00 No No Current