Home NDC 62756-200 TIAGABINE HYDROCHLORIDE
Product NDC 62756-200
11-digit product format 627560200
Labeler code 62756
Product ID 62756-200_57975e74-e45b-4fd9-9718-bfc9690acae5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TIAGABINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA077555
Marketing category ANDA
Marketing start 2011-11-04
Substance TIAGABINE HYDROCHLORIDE
Active strength 2 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077555-001 TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL 2011-11-04 A077555-002 TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL 2011-11-04
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 · 82 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 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL 2011-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL 2011-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL 2011-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL 2011-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL 2011-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL 2011-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077555-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2011-11-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077555-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2011-11-04 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TIAGABINE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIAGABINE HYDROCHLORIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DQH6T6D8OY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1299911 Internal RxNorm lookup 1299917 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62756-200-18 TIAGABINE HYDROCHLORIDE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 9 62756-200-83 TIAGABINE HYDROCHLORIDE 30 in 1 BOTTLE TABLET, FILM COATED 30 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TIAGABINE HYDROCHLORIDE ACTIVE INGREDIENT DQH6T6D8OY TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 TIAGABINE ACTIVE MOIETY Z80I64HMNP TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62756-200 TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20181102_7eeb2d81-c5d7-46a0-aa5c-149b55df71bd.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.
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 62756-200-18 62756020018 1000 TABLET, FILM COATED in 1 BOTTLE (62756-200-18) 2011-11-04 0000-00-00 No No Current 62756-200-83 62756020083 30 TABLET, FILM COATED in 1 BOTTLE (62756-200-83) 2011-11-04 0000-00-00 No No Current