Home NDC 70515-604-15 Zanaflex
Product NDC 70515-604
Requested package NDC 70515-604-15
11-digit product format 705150604
Labeler code 70515
Product ID 70515-604_3468e009-cfd1-f217-e063-6294a90a1429
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tizanidine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Covis Pharma US, Inc
Application NDA021447
Marketing category NDA
Marketing start 2018-08-01
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 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…
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 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 · 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 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…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021447-002 ZANAFLEX EQ 4MG BASE CAPSULE / ORAL AB RLD 2002-08-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021447-003 ZANAFLEX EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2002-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021447-001 ZANAFLEX EQ 2MG BASE CAPSULE / ORAL AB RLD 2002-08-29 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 Zanaflex
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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 153735 Internal RxNorm lookup 313413 Internal RxNorm lookup 485484 Internal RxNorm lookup 485485 Internal RxNorm lookup 485486 Internal RxNorm lookup 580267 Internal RxNorm lookup 583165 Internal RxNorm lookup 583211 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 70515-604-15 Zanaflex 150 in 1 BOTTLE CAPSULE 150 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70515-604 ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [COVIS PHARMA US, INC] 6 Current NDC, Legacy NDC, 1 package rows 20250507_043d9e51-bfa2-4add-9058-5ece332f7e99.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 Units Marketing start Marketing end Sample Exclude flag Status 70515-604-15 70515060415 150 CAPSULE in 1 BOTTLE (70515-604-15) 150 capsule 2018-08-01 0000-00-00 No No Current