Home NDC 65162-686 Felbamate
Product NDC 65162-686
11-digit product format 651620686
Labeler code 65162
Product ID 65162-686_5ae2c0c1-5f34-4c23-bb17-169302c2253f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Felbamate
Dosage form SUSPENSION
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA202385
Marketing category ANDA
Marketing start 2011-12-16
Substance FELBAMATE
Active strength 600 mg/5mL
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 65162-686 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 65162-686 65162-686-90 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 65162-686 65162-686-88 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202385-001 FELBAMATE FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202385-001 AB
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 2 · 41 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 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202385-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2011-12-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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/5mL
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 310285 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65162-686-88 Felbamate 237 mL in 1 BOTTLE SUSPENSION 237 14 65162-686-90 Felbamate 473 mL in 1 BOTTLE SUSPENSION 473 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FELBAMATE ACTIVE INGREDIENT X72RBB02N8 FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 FELBAMATE ACTIVE MOIETY X72RBB02N8 FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 SORBITOL INACTIVE INGREDIENT 506T60A25R FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 WATER INACTIVE INGREDIENT 059QF0KO0R FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-686 FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS LLC] 14 Current NDC, Legacy NDC, 2 package rows 20241027_2e325d79-d0a4-4af7-b09b-96ee5a5b2a37.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 65162-686-88 65162068688 237 mL in 1 BOTTLE (65162-686-88) 237 ml 2011-12-16 0000-00-00 No No Current 65162-686-90 65162068690 473 mL in 1 BOTTLE (65162-686-90) 473 ml 2011-12-16 0000-00-00 No No Current