Home NDC 0591-2789 tizanidine hydrochloride
Product NDC 0591-2789
11-digit product format 005912789
Labeler code 0591
Product ID 0591-2789_5c8f8c47-4f62-4954-8135-957c967dd7cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tizanidine hydrochloride
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA021447
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2012-02-06
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N021447-001 ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 N021447-002 ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 N021447-003 ZANAFLEX TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB RLD 2002-08-29
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 · 126 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 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD 2002-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD 2002-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD 2002-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD 2002-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD 2002-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD 2002-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD 2002-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD 2002-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD 2002-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD 2002-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD 2002-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD 2002-08-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD 2002-08-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base tizanidine hydrochloride
Listing expiration 2026-12-31 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 · 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 0591-2789-86 tizanidine hydrochloride 150 in 1 BOTTLE, PLASTIC CAPSULE, GELATIN COATED 150 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TIZANIDINE HYDROCHLORIDE ACTIVE INGREDIENT B53E3NMY5C TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] 6 TIZANIDINE ACTIVE MOIETY 6AI06C00GW TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] 6 GELATIN INACTIVE INGREDIENT 2G86QN327L TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] 6 SUCROSE INACTIVE INGREDIENT C151H8M554 TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-2789 TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] 14 Current NDC, Legacy NDC, 1 package rows 20240608_cb8b01b3-bcec-4762-9d67-0db018ef6b22.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0591-2789-86 00591278986 150 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0591-2789-86) 2012-02-06 0000-00-00 No No Current