Tizanidine

Product NDC
69420-1502
11-digit product format
694201502
Labeler code
69420
Product ID
69420-1502_0c48e5d4-3dbb-43f1-ae47-3a34a6f912c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
SA3, LLC
Application
ANDA209605
Marketing category
ANDA
Marketing start
2018-10-01
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69420-1502DDiscontinued by firm2026-10-20
excluded packagepackage69420-150269420-1502-1DDiscontinued by firm2026-10-20

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69420-1502-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69420-1502-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69420-1502-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69420-1502-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69420-1502-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69420-1502-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69420-1502-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69420-1502-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69420-1502-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69420-1502-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69420-1502-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69420-1502-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69420-1502-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69420-1502-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69420-1502-1IInactivated by FDAbd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209605-001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-04
A209605-002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-04
A209605-003TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A209605-001AB
A209605-002AB
A209605-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-04c2088c7a36db…
2026-10-15 13:18:302026-09A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-04c2088c7a36db…
2026-10-15 13:18:302026-09A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-04c2088c7a36db…
2026-09-14 22:38:342026-08A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-0484e616aacf4f…
2026-09-14 22:38:342026-08A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-0484e616aacf4f…
2026-09-14 22:38:342026-08A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-0484e616aacf4f…
2026-08-18 06:07:402026-07A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-04caaa826d4ba7…
2026-08-18 06:07:402026-07A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-04caaa826d4ba7…
2026-08-18 06:07:402026-07A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-0479d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-11-12 02:37 UTC2020-11A209605-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209605-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A209605-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A209605-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209605-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A209605-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A209605-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209605-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A209605-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A209605-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209605-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209605-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209605-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209605-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A209605-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A209605-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209605-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209605-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209605-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209605-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209605-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209605-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209605-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209605-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209605-003AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209605-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209605-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209605-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209605-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209605-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209605-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209605-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A209605-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A209605-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209605-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A209605-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A209605-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209605-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209605-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209605-003AB13a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69420-1502-1EA - Each69420-150287ba9830-a2cf-468a-9db4-733cd62496b012018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69420-1502-169420150201150 CAPSULE in 1 BOTTLE (69420-1502-1) 150 capsule2018-10-010000-00-00NoNoCurrent