Home NDC 71610-114 tizanidine hydrochloride
Product NDC 71610-114
11-digit product format 716100114
Labeler code 71610
Product ID 71610-114_8826f454-0316-4981-8c28-9bf20cf956f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tizanidine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA076280
Marketing category ANDA
Marketing start 2002-06-27
Marketing end 0000-00-00
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 2020-12-31
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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71610-114-30 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71610-114-60 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71610-114-53 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71610-114-30 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71610-114-60 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71610-114-53 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 88 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 2026-10-15 13:18:30 2026-09 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076280-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2002-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076280-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2002-06-27 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 52 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-114 TIZANIDINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC 20180831_2d354fee-9440-4d56-8990-fe1dcc2305fc.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71610-114-30 71610011430 30 TABLET in 1 BOTTLE (71610-114-30) 30 tablet 2018-08-09 0000-00-00 No No Current 71610-114-53 71610011453 60 TABLET in 1 BOTTLE (71610-114-53) 60 tablet 2018-08-09 0000-00-00 No No Current 71610-114-60 71610011460 90 TABLET in 1 BOTTLE (71610-114-60) 90 tablet 2018-08-09 0000-00-00 No No Current