Home NDC 45865-954 Tizanidine Hydrochloride
Product NDC 45865-954
11-digit product format 458650954
Labeler code 45865
Product ID 45865-954_9addc6af-dffb-0942-e053-2a95a90ac997
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tizanidine Hydrochloride
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler medsource pharmaceuticals
Application ANDA078868
Marketing category ANDA
Marketing start 2012-02-06
Marketing end 0000-00-00
Substance TIZANIDINE HYDROCHLORIDE
Active strength 6 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 45865-954-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 45865-954-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 45865-954-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 45865-954-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 45865-954-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 45865-954-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 45865-954-30 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 45865-954-30 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 45865-954-30 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 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 · 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 A078868-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2012-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078868-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE CAPSULE / ORAL AB 2012-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078868-003 TIZANIDINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2012-02-03 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45865-954-30 Tizanidine Hydrochloride 30 in 1 BOTTLE CAPSULE, GELATIN COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45865-954 TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [MEDSOURCE PHARMACEUTICALS] 1 Legacy NDC, 1 package rows 20191230_9addc6af-dffa-0942-e053-2a95a90ac997.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 45865-954-30 45865095430 30 CAPSULE, GELATIN COATED in 1 BOTTLE (45865-954-30) 2018-12-12 0000-00-00 No No Current