Home NDC 72789-327 Tizanidine
Product NDC 72789-327
11-digit product format 727890327
Labeler code 72789
Product ID 72789-327_40bb3624-175c-7967-e063-6394a90af2dd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tizanidine
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA076416
Marketing category ANDA
Marketing start 2003-12-11
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Tizanidine
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313413 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 72789-327-20 Tizanidine 20 in 1 BOTTLE, PLASTIC TABLET 20 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-327 TIZANIDINE TABLET [PD-RX PHARMACEUTICALS, INC.] 11 Current NDC, 1 package rows 20241011_fdf4f09d-4537-a438-e053-6394a90a573d.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 Sample Exclude flag Status 72789-327-20 72789032720 20 TABLET in 1 BOTTLE, PLASTIC (72789-327-20) 20 tablet 2023-06-12 No No Current