Home NDC 70771-1078 Felbamate
Product NDC 70771-1078
11-digit product format 707711078
Labeler code 70771
Product ID 70771-1078_785f1747-e29d-432a-82e7-fcaeea202327
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Felbamate
Dosage form TABLET
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA208970
Marketing category ANDA
Marketing start 2017-08-15
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 42 .
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 A208970-001 FELBAMATE FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 A208970-002 FELBAMATE FELBAMATE 600MG TABLET / ORAL AB 2017-05-30
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 · 84 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 2026-08-18 06:07:40 2026-07 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208970-001 FELBAMATE 400MG TABLET / ORAL AB 2017-05-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208970-002 FELBAMATE 600MG TABLET / ORAL AB 2017-05-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1078 FELBAMATE TABLET [ZYDUS LIFESCIENCES LIMITED] 6 Current NDC, Legacy NDC, 7 package rows 20240821_efa55cb2-b625-4392-9ddb-0a8ad8ee58c4.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 70771-1078-1 70771107801 100 TABLET in 1 BOTTLE (70771-1078-1) 100 tablet 2017-08-15 0000-00-00 No No Current 70771-1078-3 70771107803 30 TABLET in 1 BOTTLE (70771-1078-3) 30 tablet 2017-08-15 0000-00-00 No No Current 70771-1078-4 70771107804 10 BLISTER PACK in 1 CARTON (70771-1078-4) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2017-08-15 0000-00-00 No No Current 70771-1078-5 70771107805 500 TABLET in 1 BOTTLE (70771-1078-5) 500 tablet 2017-08-15 0000-00-00 No No Current 70771-1078-8 70771107808 180 TABLET in 1 BOTTLE (70771-1078-8) 180 tablet 2017-08-15 0000-00-00 No No Current 70771-1078-9 70771107809 90 TABLET in 1 BOTTLE (70771-1078-9) 90 tablet 2017-08-15 0000-00-00 No No Current