Home NDC 51525-0431 Felbamate
Product NDC 51525-0431
11-digit product format 515250431
Labeler code 51525
Product ID 51525-0431_525ae813-9695-47a8-8f75-9a3abadd3b50
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name felbamate
Dosage form TABLET
Route ORAL
Labeler Wallace Pharmaceuticals Inc.
Application NDA020189
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2011-11-11
Marketing end 0000-00-00
Substance FELBAMATE
Active strength 600 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020189-001 FELBATOL FELBAMATE 400MG TABLET / ORAL AB RLD 1993-07-29 N020189-002 FELBATOL FELBAMATE 600MG TABLET / ORAL AB RLD, RS 1993-07-29 N020189-003 FELBATOL FELBAMATE 600MG/5ML SUSPENSION / ORAL RLD 1993-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 4 · 123 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 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL RLD 1993-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 121 observed states.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51525-0431 FELBAMATE TABLET FELBAMATE SUSPENSION [WALLACE PHARMACEUTICALS INC.] 9 Legacy NDC 20250312_c0c15d60-1171-11e1-9be0-0002a5d5c51b.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Felbatol FELBAMATE Viatris Specialty LLC 2f522701-397a-11de-8a39-0800200c9a66 2025-08-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020189 application number: NDA020189
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51525-0431-1 51525043101 100 TABLET in 1 BOTTLE (51525-0431-1) 100 tablet 2011-11-11 0000-00-00 No No Current