Home NDC 16714-775 Felbamate
Product NDC 16714-775
11-digit product format 167140775
Labeler code 16714
Product ID 16714-775_c3010d7b-f928-464e-af7c-ca45a5320a20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Felbamate
Dosage form SUSPENSION
Route ORAL
Labeler NORTHSTAR RX LLC
Application ANDA206314
Marketing category ANDA
Marketing start 2018-04-10
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 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 A206314-001 FELBAMATE FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206314-001 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 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206314-001 FELBAMATE 600MG/5ML SUSPENSION / ORAL AB 2017-06-16 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16714-775-01 Felbamate 237 mL in 1 BOTTLE SUSPENSION 237 1 16714-775-02 Felbamate 473 mL in 1 BOTTLE SUSPENSION 473 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-775 FELBAMATE SUSPENSION [NORTHSTAR RX LLC] 1 Current NDC, Legacy NDC, 2 package rows 20180516_556de35d-3b98-48d3-a670-50e9d93437a4.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 16714-775-01 16714077501 237 mL in 1 BOTTLE (16714-775-01) 237 ml 2018-04-10 0000-00-00 No No Current 16714-775-02 16714077502 473 mL in 1 BOTTLE (16714-775-02) 473 ml 2018-04-10 0000-00-00 No No Current