Home NDC 42291-811-15 Tizanidine Hydrochloride
Product NDC 42291-811
Requested package NDC 42291-811-15
11-digit product format 422910811
Labeler code 42291
Product ID 42291-811_423ead2f-fbbc-830d-e063-6294a90aacfe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tizanidine Hydrochloride
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler AvKARE
Application ANDA078868
Marketing category ANDA
Marketing start 2014-06-20
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 1 .
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 A078868-001 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 A078868-002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 A078868-003 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03
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 · 123 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 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 42291-811-15 Tizanidine Hydrochloride 150 in 1 BOTTLE CAPSULE, GELATIN COATED 150 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TIZANIDINE HYDROCHLORIDE ACTIVE INGREDIENT B53E3NMY5C TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 TIZANIDINE ACTIVE MOIETY 6AI06C00GW TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 POLYVINYL ACETATE PHTHALATE INACTIVE INGREDIENT 58QVG85GW3 TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-811 TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE] 8 Current NDC, Legacy NDC, 1 package rows 20240405_acc8f9f6-ceb6-0505-8f11-fd7e1f105af3.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 Marketing start Marketing end Sample Exclude flag Status 42291-811-15 42291081115 150 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-811-15) 2014-06-20 0000-00-00 No No Current