Tizanidine Hydrochloride

Product NDC
59746-670
11-digit product format
597460670
Labeler code
59746
Product ID
59746-670_b384b1a9-6301-4d3f-a6f1-4deb5f58e6e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA209605
Marketing category
ANDA
Marketing start
2017-08-04
Marketing end
0000-00-00
Substance
TIZANIDINE
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

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59746-670DDiscontinued by firm2026-08-03
excluded packagepackage59746-67059746-670-01DDiscontinued by firm2026-08-03
excluded packagepackage59746-67059746-670-10DDiscontinued by firm2026-08-03
excluded packagepackage59746-67059746-670-30DDiscontinued by firm2026-08-03
excluded packagepackage59746-67059746-670-34DDiscontinued by firm2026-08-03

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 · 75 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-670-34d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-670-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-670-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-670-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-670-34f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-670-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-670-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-670-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-670-342ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-670-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-670-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-670-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-670-34a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-670-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-670-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-670-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-670-34cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-670-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-670-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-670-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-670-34cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-670-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-670-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-670-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-670-34302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-670-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-670-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-670-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-670-34ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-670-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-670-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-670-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-670-340efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-670-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-670-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-670-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-670-34ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-670-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-670-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-670-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-670-34367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-670-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-670-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-670-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-670-34557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-670-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-670-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-670-30557ba5c1ecfa…9c80585c8c6e…

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-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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209605-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2017-08-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209605-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2017-08-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209605-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2017-08-048072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209605-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209605-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209605-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209605-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209605-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209605-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209605-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209605-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209605-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209605-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209605-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209605-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209605-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209605-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209605-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209605-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209605-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209605-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209605-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209605-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209605-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209605-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209605-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209605-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209605-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209605-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209605-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209605-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209605-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209605-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209605-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209605-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209605-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209605-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209605-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209605-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209605-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209605-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209605-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209605-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
59746-670-012025-12-31These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996
59746-670-102025-12-31These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996
59746-670-302025-12-31These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996
59746-670-342025-12-31These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996
59746-670-012023-01-30These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996
59746-670-102023-01-30These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996
59746-670-302023-01-30These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996
59746-670-342023-01-30These highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 1996

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-670-34EA - Each59746-6709649a135-e5ca-44bf-99b8-abf8891f4ab212018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-670TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3Legacy NDC20170811_e803d28e-0610-a52c-3295-dd2d148531aa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-670-0159746067001100 CAPSULE in 1 BOTTLE (59746-670-01) 100 capsule2017-08-040000-00-00NoNoCurrent
59746-670-10597460670101000 CAPSULE in 1 BOTTLE (59746-670-10) 1000 capsule2017-08-040000-00-00NoNoCurrent
59746-670-305974606703030 CAPSULE in 1 BOTTLE (59746-670-30) 30 capsule2017-08-040000-00-00NoNoCurrent
59746-670-3459746067034150 CAPSULE in 1 BOTTLE (59746-670-34) 150 capsule2017-08-040000-00-00NoNoCurrent