Home NDC 49884-947 TIZANIDINE
Product NDC 49884-947
11-digit product format 498840947
Labeler code 49884
Product ID 49884-947_4f93387a-b669-4a5e-ba42-fa9eeaa3197a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TIZANIDINE
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA207170
Marketing category ANDA
Marketing start 2017-01-17
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 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 2 · 72 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A207170-001 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 A207170-002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26
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 · 82 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 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207170-001 TIZANIDINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2017-01-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207170-002 TIZANIDINE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2017-01-26 782e0a99824c…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49884-947-01 49884094701 100 TABLET in 1 BOTTLE (49884-947-01) 100 tablet 2017-01-17 0000-00-00 No No Current 49884-947-05 49884094705 500 TABLET in 1 BOTTLE (49884-947-05) 500 tablet 2017-01-17 0000-00-00 No No Current 49884-947-10 49884094710 1000 TABLET in 1 BOTTLE (49884-947-10) 1000 tablet 2017-01-17 0000-00-00 No No Current 49884-947-11 49884094711 30 TABLET in 1 BOTTLE (49884-947-11) 30 tablet 2017-01-17 0000-00-00 No No Current