Home NDC 65162-735 Felbamate
Product NDC 65162-735
11-digit product format 651620735
Labeler code 65162
Product ID 65162-735_28bca98d-c89a-492a-a3e5-405098e33919
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Felbamate
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA201680
Marketing category ANDA
Marketing start 2011-09-16
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 A201680-001 FELBAMATE FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 A201680-002 FELBAMATE FELBAMATE 600MG TABLET / ORAL AB 2011-09-13
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 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201680-001 FELBAMATE 400MG TABLET / ORAL AB 2011-09-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201680-002 FELBAMATE 600MG TABLET / ORAL AB 2011-09-13 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198358 Internal RxNorm lookup 198359 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FELBAMATE ACTIVE INGREDIENT X72RBB02N8 FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 FELBAMATE ACTIVE MOIETY X72RBB02N8 FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 FELBAMATE ACTIVE INGREDIENT X72RBB02N8 FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT] 2 FELBAMATE ACTIVE MOIETY X72RBB02N8 FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-735 FELBAMATE TABLET [AMNEAL PHARMACEUTICALS LLC] 12 Current NDC, Legacy NDC, 5 package rows 20241012_aa3fd2c0-98d6-45f3-81b0-a902526214c6.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 · 2 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 65162-735-03 65162073503 30 TABLET in 1 BOTTLE (65162-735-03) 30 tablet 2011-09-16 0000-00-00 No No Current 65162-735-09 65162073509 90 TABLET in 1 BOTTLE (65162-735-09) 90 tablet 2011-09-16 0000-00-00 No No Current 65162-735-18 65162073518 180 TABLET in 1 BOTTLE (65162-735-18) 180 tablet 2011-09-16 0000-00-00 No No Current 65162-735-27 65162073527 270 TABLET in 1 BOTTLE (65162-735-27) 270 tablet 2011-09-16 0000-00-00 No No Current 65162-735-50 65162073550 500 TABLET in 1 BOTTLE (65162-735-50) 500 tablet 2011-09-16 0000-00-00 No No Current