Home NDC 63629-1944 Felbamate
Product NDC 63629-1944
11-digit product format 636291944
Labeler code 63629
Product ID 63629-1944_27426bc1-4084-4e2f-a06f-05830677d2a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Felbamate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA202284
Marketing category ANDA
Marketing start 2018-09-04
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202284-001 FELBAMATE FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 A202284-002 FELBAMATE FELBAMATE 600MG TABLET / ORAL AB 2015-11-04
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 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 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202284-001 FELBAMATE 400MG TABLET / ORAL AB 2015-11-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A202284-002 FELBAMATE 600MG TABLET / ORAL AB 2015-11-04 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Felbamate
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198359 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 63629-1944-1 Felbamate 100 in 1 BOTTLE TABLET 100 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-1944 FELBAMATE TABLET [BRYANT RANCH PREPACK] 104 Current NDC, Legacy NDC, 1 package rows 20250321_3170233c-0452-4150-9e4c-dfffcde7424e.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Felbamate FELBAMATE Bryant Ranch Prepack 6afd77f2-4525-42f4-a4b1-94159c401dd2 2026-03-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202284 application number: ANDA202284 Felbamate FELBAMATE Bryant Ranch Prepack d6eaf094-09e2-480c-bea9-7a2768aad884 2026-03-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202284 application number: ANDA202284 Felbamate FELBAMATE Bryant Ranch Prepack 696e3cbb-a431-4f29-acbd-1db8e9aaef93 2026-03-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202284 application number: ANDA202284 Felbamate FELBAMATE ANI Pharmaceuticals, Inc. 17850520-f823-4d05-8f9b-5eadfa68bae2 2025-11-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202284 application number: ANDA202284 Felbamate FELBAMATE Bryant Ranch Prepack 3170233c-0452-4150-9e4c-dfffcde7424e 2025-03-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202284 application number: ANDA202284 ndc (product): 63629-1944
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 63629-1944-1 63629194401 100 TABLET in 1 BOTTLE (63629-1944-1) 100 tablet 2021-01-19 0000-00-00 No No Current