Tizanidine Hydrochloride

Product NDC
59651-316
Requested package NDC
59651-316-15
11-digit product format
596510316
Labeler code
59651
Product ID
59651-316_c5462b0a-179b-449f-87e9-1ccfa18367b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA213544
Marketing category
ANDA
Marketing start
2020-03-24
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
6 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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage59651-31659651-316-15UNFINISHEDActive or certified unfinished drug listing2026-08-17

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 · 19 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A213544-001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-24
A213544-002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-24
A213544-003TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213544-001AB
A213544-002AB
A213544-003AB

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 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07A213544-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07A213544-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213544-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213544-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213544-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213544-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213544-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213544-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213544-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213544-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213544-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213544-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213544-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213544-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213544-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213544-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213544-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213544-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213544-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213544-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A213544-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A213544-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213544-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213544-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213544-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2020-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213544-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2020-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213544-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2020-03-241e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213544-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213544-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213544-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213544-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213544-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213544-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213544-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213544-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213544-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213544-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213544-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213544-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213544-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213544-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213544-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213544-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213544-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213544-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213544-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213544-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213544-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213544-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213544-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213544-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213544-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213544-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213544-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213544-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213544-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213544-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213544-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213544-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213544-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213544-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213544-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213544-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213544-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213544-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213544-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213544-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B53E3NMY5CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485484Internal RxNorm lookup
485485Internal RxNorm lookup
485486Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19cf46b5-d8dc-44cb-83d6-bacea0870dbeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0ff02d8-b711-423c-b7d1-ada00d81c743Product name120250805
9fd28b3a-d1bb-a2ce-ffa3-c3dd28536a01Product name820250313
b404127e-1c01-47bb-874e-db1e0b6bd9afProduct name420250313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-316-77Tizanidine Hydrochloride150 in 1 BOTTLECAPSULE1504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-316-77EA - Each59651-316f368015c-bb99-409d-b82a-608044f800d712020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-316TIZANIDINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 1 package rows20250123_19cf46b5-d8dc-44cb-83d6-bacea0870dbe.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDEAurobindo Pharma Limited19cf46b5-d8dc-44cb-83d6-bacea0870dbe2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213544
application number: ANDA213544
ndc (product): 59651-316

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485486tiZANidine HCl 2 MG Oral CapsulePSN19cf46b5-d8dc-44cb-83d6-bacea0870dbe4
485485tiZANidine HCl 4 MG Oral CapsulePSN19cf46b5-d8dc-44cb-83d6-bacea0870dbe4
485484tiZANidine HCl 6 MG Oral CapsulePSN19cf46b5-d8dc-44cb-83d6-bacea0870dbe4
485486tizanidine 2 MG Oral CapsuleSCD19cf46b5-d8dc-44cb-83d6-bacea0870dbe4
485485tizanidine 4 MG Oral CapsuleSCD19cf46b5-d8dc-44cb-83d6-bacea0870dbe4
485484tizanidine 6 MG Oral CapsuleSCD19cf46b5-d8dc-44cb-83d6-bacea0870dbe4
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSY19cf46b5-d8dc-44cb-83d6-bacea0870dbe4
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY19cf46b5-d8dc-44cb-83d6-bacea0870dbe4
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY19cf46b5-d8dc-44cb-83d6-bacea0870dbe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
59651-316-15596510316151500 CAPSULE in 1 BAG (59651-316-15)1500 capsule24-MAR-20Current