Tiagabine Hydrochloride

Product NDC
16714-154
11-digit product format
167140154
Labeler code
16714
Product ID
16714-154_03a5672d-d01c-495c-91d9-d1f4e8426093
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tiagabine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA214816
Marketing category
ANDA
Marketing start
2021-11-24
Marketing end
0000-00-00
Substance
TIAGABINE HYDROCHLORIDE
Active strength
16 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct16714-154DDiscontinued by firm2026-08-07
excluded packagepackage16714-15416714-154-01DDiscontinued by firm2026-08-07

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 · 12 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 packagepackage16714-154-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16714-154-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16714-154-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16714-154-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16714-154-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16714-154-01cdf11ea48f46…ba0047e9e063…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214816-001TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDE2MGTABLET / ORALAB2021-11-16
A214816-002TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDE4MGTABLET / ORALAB2021-11-16
A214816-003TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDE12MGTABLET / ORALAB2021-11-16
A214816-004TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDE16MGTABLET / ORALAB2021-11-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A214816-001AB
A214816-002AB
A214816-003AB
A214816-004AB

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
2026-02-19 14:30 UTC2026-02A214816-001TIAGABINE HYDROCHLORIDE2MGTABLET / ORALAB2021-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214816-002TIAGABINE HYDROCHLORIDE4MGTABLET / ORALAB2021-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214816-003TIAGABINE HYDROCHLORIDE12MGTABLET / ORALAB2021-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214816-004TIAGABINE HYDROCHLORIDE16MGTABLET / ORALAB2021-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214816-001TIAGABINE HYDROCHLORIDE2MGTABLET / ORALAB2021-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214816-002TIAGABINE HYDROCHLORIDE4MGTABLET / ORALAB2021-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214816-003TIAGABINE HYDROCHLORIDE12MGTABLET / ORALAB2021-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214816-004TIAGABINE HYDROCHLORIDE16MGTABLET / ORALAB2021-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A214816-001TIAGABINE HYDROCHLORIDE2MGTABLET / ORALAB2021-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214816-002TIAGABINE HYDROCHLORIDE4MGTABLET / ORALAB2021-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214816-003TIAGABINE HYDROCHLORIDE12MGTABLET / ORALAB2021-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214816-004TIAGABINE HYDROCHLORIDE16MGTABLET / ORALAB2021-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214816-001TIAGABINE HYDROCHLORIDE2MGTABLET / ORALAB2021-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214816-002TIAGABINE HYDROCHLORIDE4MGTABLET / ORALAB2021-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214816-003TIAGABINE HYDROCHLORIDE12MGTABLET / ORALAB2021-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214816-004TIAGABINE HYDROCHLORIDE16MGTABLET / ORALAB2021-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214816-001TIAGABINE HYDROCHLORIDE2MGTABLET / ORALAB2021-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214816-002TIAGABINE HYDROCHLORIDE4MGTABLET / ORALAB2021-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214816-003TIAGABINE HYDROCHLORIDE12MGTABLET / ORALAB2021-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214816-004TIAGABINE HYDROCHLORIDE16MGTABLET / ORALAB2021-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214816-001TIAGABINE HYDROCHLORIDE2MGTABLET / ORALAB2021-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214816-002TIAGABINE HYDROCHLORIDE4MGTABLET / ORALAB2021-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214816-003TIAGABINE HYDROCHLORIDE12MGTABLET / ORALAB2021-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214816-004TIAGABINE HYDROCHLORIDE16MGTABLET / ORALAB2021-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214816-001TIAGABINE HYDROCHLORIDE2MGTABLET / ORALAB2021-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214816-002TIAGABINE HYDROCHLORIDE4MGTABLET / ORALAB2021-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214816-003TIAGABINE HYDROCHLORIDE12MGTABLET / ORALAB2021-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214816-004TIAGABINE HYDROCHLORIDE16MGTABLET / ORALAB2021-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214816-001TIAGABINE HYDROCHLORIDE2MGTABLET / ORALAB2021-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214816-002TIAGABINE HYDROCHLORIDE4MGTABLET / ORALAB2021-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214816-003TIAGABINE HYDROCHLORIDE12MGTABLET / ORALAB2021-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214816-004TIAGABINE HYDROCHLORIDE16MGTABLET / ORALAB2021-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214816-001TIAGABINE HYDROCHLORIDE2MGTABLET / ORALAB2021-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214816-002TIAGABINE HYDROCHLORIDE4MGTABLET / ORALAB2021-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214816-003TIAGABINE HYDROCHLORIDE12MGTABLET / ORALAB2021-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214816-004TIAGABINE HYDROCHLORIDE16MGTABLET / ORALAB2021-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214816-001TIAGABINE HYDROCHLORIDE2MGTABLET / ORALAB2021-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A214816-002TIAGABINE HYDROCHLORIDE4MGTABLET / ORALAB2021-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A214816-003TIAGABINE HYDROCHLORIDE12MGTABLET / ORALAB2021-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A214816-004TIAGABINE HYDROCHLORIDE16MGTABLET / ORALAB2021-11-16d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214816-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214816-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214816-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214816-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214816-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214816-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214816-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214816-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214816-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214816-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214816-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214816-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214816-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214816-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214816-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214816-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214816-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214816-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214816-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214816-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214816-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214816-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214816-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214816-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214816-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214816-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214816-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214816-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214816-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214816-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214816-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214816-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214816-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214816-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214816-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214816-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214816-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214816-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214816-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214816-004AB1d06236e962d9…

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
Tiagabine HydrochlorideTIAGABINE HYDROCHLORIDENovadoz Pharmaceuticals LLC7c034fe0-cdac-49e1-8e39-592846ea3bec2021-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214816
application number: ANDA214816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-154-011671401540130 TABLET in 1 BOTTLE (16714-154-01) 30 tablet2021-11-240000-00-00NoNoCurrent