Home NDC 63459-404-30 GABITRIL
Product NDC 63459-404
Requested package NDC 63459-404-30
11-digit product format 634590404
Labeler code 63459
Product ID 63459-404_cdd94737-c30c-4035-8809-78c0ba68b88d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tiagabine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cephalon, LLC
Application NDA020646
Marketing category NDA
Marketing start 2001-04-01
Marketing end 0000-00-00
Substance TIAGABINE HYDROCHLORIDE
Active strength 4 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2023-12-31
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 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020646-001 GABITRIL TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB RLD, RS 1997-09-30 N020646-002 GABITRIL TIAGABINE HYDROCHLORIDE 12MG TABLET / ORAL AB RLD 1997-09-30 N020646-003 GABITRIL TIAGABINE HYDROCHLORIDE 16MG TABLET / ORAL AB RLD 1997-09-30 N020646-004 GABITRIL TIAGABINE HYDROCHLORIDE 20MG TABLET / ORAL 1997-09-30 N020646-005 GABITRIL TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB RLD 1999-04-16 N020646-006 GABITRIL TIAGABINE HYDROCHLORIDE 6MG TABLET / ORAL 2005-11-29 N020646-007 GABITRIL TIAGABINE HYDROCHLORIDE 8MG TABLET / ORAL 2005-11-29 N020646-008 GABITRIL TIAGABINE HYDROCHLORIDE 10MG TABLET / ORAL 2005-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 9 · 328 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 N020646-001 GABITRIL 4MG TABLET / ORAL AB RLD, RS 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020646-002 GABITRIL 12MG TABLET / ORAL AB RLD 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020646-003 GABITRIL 16MG TABLET / ORAL AB RLD 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020646-004 GABITRIL 20MG TABLET / ORAL 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020646-005 GABITRIL 2MG TABLET / ORAL AB RLD 1999-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020646-006 GABITRIL 6MG TABLET / ORAL 2005-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020646-007 GABITRIL 8MG TABLET / ORAL 2005-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020646-008 GABITRIL 10MG TABLET / ORAL 2005-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020646-001 GABITRIL 4MG TABLET / ORAL AB RLD, RS 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020646-002 GABITRIL 12MG TABLET / ORAL AB RLD 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020646-003 GABITRIL 16MG TABLET / ORAL AB RLD 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020646-004 GABITRIL 20MG TABLET / ORAL 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020646-005 GABITRIL 2MG TABLET / ORAL AB RLD 1999-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020646-006 GABITRIL 6MG TABLET / ORAL 2005-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020646-007 GABITRIL 8MG TABLET / ORAL 2005-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020646-008 GABITRIL 10MG TABLET / ORAL 2005-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020646-001 GABITRIL 4MG TABLET / ORAL AB RLD, RS 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020646-002 GABITRIL 12MG TABLET / ORAL AB RLD 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020646-003 GABITRIL 16MG TABLET / ORAL AB RLD 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020646-004 GABITRIL 20MG TABLET / ORAL 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020646-005 GABITRIL 2MG TABLET / ORAL AB RLD 1999-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020646-006 GABITRIL 6MG TABLET / ORAL 2005-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020646-007 GABITRIL 8MG TABLET / ORAL 2005-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020646-008 GABITRIL 10MG TABLET / ORAL 2005-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020646-001 GABITRIL 4MG TABLET / ORAL AB RLD, RS 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020646-002 GABITRIL 12MG TABLET / ORAL AB RLD 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020646-003 GABITRIL 16MG TABLET / ORAL AB RLD 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020646-004 GABITRIL 20MG TABLET / ORAL 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020646-005 GABITRIL 2MG TABLET / ORAL AB RLD 1999-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020646-006 GABITRIL 6MG TABLET / ORAL 2005-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020646-007 GABITRIL 8MG TABLET / ORAL 2005-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020646-008 GABITRIL 10MG TABLET / ORAL 2005-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020646-001 GABITRIL 4MG TABLET / ORAL AB RLD, RS 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020646-002 GABITRIL 12MG TABLET / ORAL AB RLD 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020646-003 GABITRIL 16MG TABLET / ORAL AB RLD 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020646-004 GABITRIL 20MG TABLET / ORAL 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020646-005 GABITRIL 2MG TABLET / ORAL AB RLD 1999-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020646-006 GABITRIL 6MG TABLET / ORAL 2005-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020646-007 GABITRIL 8MG TABLET / ORAL 2005-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020646-008 GABITRIL 10MG TABLET / ORAL 2005-11-29 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product No
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIAGABINE HYDROCHLORIDE 4 mg/1
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TIAGABINE HYDROCHLORIDE ACTIVE INGREDIENT DQH6T6D8OY GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 TIAGABINE ACTIVE MOIETY Z80I64HMNP GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 HYDROGENATED SOYBEAN OIL INACTIVE INGREDIENT A2M91M918C GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED] 15 TIAGABINE HYDROCHLORIDE ACTIVE INGREDIENT DQH6T6D8OY GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2 tiagabine ACTIVE MOIETY Z80I64HMNP GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT] 2
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63459-404-30 63459040430 30 TABLET, FILM COATED in 1 BOTTLE (63459-404-30) 2010-02-08 0000-00-00 No No Current