Home NDC 0037-0431 Felbatol
Product NDC 0037-0431
11-digit product format 000370431
Labeler code 0037
Product ID 0037-0431_374f8c69-4219-47fd-aeda-8edc73da5411
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name felbamate
Dosage form TABLET
Route ORAL
Labeler Viatris Specialty LLC
Application NDA020189
Marketing category NDA
Marketing start 1993-07-29
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 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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base Felbatol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FELBAMATE 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X72RBB02N8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198358 Internal RxNorm lookup 198359 Internal RxNorm lookup 209026 Internal RxNorm lookup 209027 Internal RxNorm lookup 209028 Internal RxNorm lookup 310285 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 0037-0431-01 Felbatol 100 in 1 BOTTLE, PLASTIC TABLET 100 16
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0037-0431 FELBATOL (FELBAMATE) TABLET FELBATOL (FELBAMATE) SUSPENSION [MEDA PHARMACEUTICALS INC.] 13 Current NDC, Legacy NDC, 1 package rows 20241013_2f522701-397a-11de-8a39-0800200c9a66.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 Units Marketing start Marketing end Sample Exclude flag Status 0037-0431-01 00037043101 100 TABLET in 1 BOTTLE, PLASTIC (0037-0431-01) 100 tablet 1993-07-29 0000-00-00 No No Current