Home NDC 42291-808 Tizanidine
Product NDC 42291-808
11-digit product format 422910808
Labeler code 42291
Product ID 42291-808_d5c9e83d-60d6-fb9c-e053-2995a90a9731
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tizanidine
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA076416
Marketing category ANDA
Marketing start 2015-07-28
Marketing end 0000-00-00
Substance TIZANIDINE HYDROCHLORIDE
Active strength 2 mg/1
Pharmacologic classes Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A076416-001 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 A076416-002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 86 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 2026-09-14 22:38:34 2026-08 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076416-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2003-09-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076416-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2003-09-29 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TIZANIDINE HYDROCHLORIDE ACTIVE INGREDIENT B53E3NMY5C TIZANIDINE TABLET [AVKARE, INC.] 2 TIZANIDINE ACTIVE MOIETY 6AI06C00GW TIZANIDINE TABLET [AVKARE, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TIZANIDINE TABLET [AVKARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TIZANIDINE TABLET [AVKARE, INC.] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TIZANIDINE TABLET [AVKARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TIZANIDINE TABLET [AVKARE, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TIZANIDINE TABLET [AVKARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-808 TIZANIDINE TABLET [AVKARE] 7 Legacy NDC 20240111_150c131c-3dc5-8417-2dc0-d0d440fb1d34.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 2 of 2 · 21 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tizanidine TIZANIDINE Sun Pharmaceutical Industries, Inc. 4659df31-8b89-4eff-9d86-7b7e38de416b 2020-10-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076416 application number: ANDA076416
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 42291-808-15 42291080815 150 TABLET in 1 BOTTLE (42291-808-15) 150 tablet 2015-07-28 0000-00-00 No No Current