Home NDC 66689-825-08 Felbamate
Product NDC 66689-825
Requested package NDC 66689-825-08
11-digit product format 666890825
Labeler code 66689
Product ID 66689-825_c5c995bf-8fbe-415d-94f5-22c875f086c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Felbamate
Dosage form SUSPENSION
Route ORAL
Labeler VistaPharm, Inc.
Application ANDA211333
Marketing category ANDA
Marketing start 2019-06-24
Marketing end 2024-01-31
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A211333-001 FELBAMATE FELBAMATE 600MG/5ML SUSPENSION / ORAL AB RS 2019-05-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211333-001 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 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB RS 2019-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211333-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2019-05-31 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 Felbamate FELBAMATE Novitium Pharma LLC 81c8a2e1-732c-4467-84e9-53fef1655ee2 2022-09-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211333 application number: ANDA211333
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66689-825-08 66689082508 237 mL in 1 BOTTLE, PLASTIC (66689-825-08) 237 ml 2019-06-24 2024-01-31 No No Current