Home NDC 43376-322 Fintepla
Product NDC 43376-322
11-digit product format 433760322
Labeler code 43376
Product ID 43376-322_42264a61-0fc3-3a99-e063-6294a90a9595
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fenfluramine
Dosage form SOLUTION
Route ORAL
Labeler UCB, Inc.
Application NDA212102
Marketing category NDA
Marketing start 2020-07-15
Substance FENFLURAMINE
Active strength 2.2 mg/mL
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 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 43376-322 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43376-322 43376-322-30 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43376-322 43376-322-36 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 N212102-001 FINTEPLA FENFLURAMINE HYDROCHLORIDE EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25
Orange Book patents# Current patent rows page 1 of 1 · 31 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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.
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 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 23 · 907 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N212102-001 10478441 2033-05-03 U-2860 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10478442 2033-05-03 U-2860 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 12097206 2033-05-03 U-4013 2024-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9549909 2033-05-03 U-2858 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9603814 2033-05-03 U-2858 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9603815 2033-05-03 U-2858 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9610260 2033-05-03 U-2858 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10478441*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10478442*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 12097206*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9549909*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9603814*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9603815*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9610260*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10947183 2036-12-20 Drug substance, Drug product 2021-04-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10947183*PED 2037-06-20 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10603290 2037-08-02 U-2861 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10603290 2037-08-02 U-3347 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11040018 2037-08-02 U-2861 2021-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11040018 2037-08-02 U-3347 2021-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11406606 2037-08-02 U-3406 2022-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11406606 2037-08-02 U-3407 2022-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11759440 2037-08-02 U-3694 2023-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11786487 2037-08-02 U-3733 2023-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10603290*PED 2038-02-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11040018*PED 2038-02-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11406606*PED 2038-02-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11759440*PED 2038-02-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11786487*PED 2038-02-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10452815 2038-06-29 U-2859 Delist requested 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10452815*PED 2038-12-29 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 10478441 2033-05-03 U-2860 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 10478442 2033-05-03 U-2860 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 12097206 2033-05-03 U-4013 2024-10-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 9549909 2033-05-03 U-2858 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 9603814 2033-05-03 U-2858 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 9603815 2033-05-03 U-2858 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 9610260 2033-05-03 U-2858 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 10478441*PED 2033-11-03 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 10478442*PED 2033-11-03 Pediatric extension 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 200 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fintepla
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FENFLURAMINE 2.2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2DS058H2CF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2381138 Internal RxNorm lookup 2381144 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 43376-322-30 Fintepla 30 mL in 1 BOTTLE, PLASTIC SOLUTION 30 16 43376-322-30 Fintepla 1 in 1 CARTON SOLUTION 1 16 43376-322-36 Fintepla 360 mL in 1 BOTTLE, PLASTIC SOLUTION 360 16 43376-322-36 Fintepla 1 in 1 CARTON SOLUTION 1 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43376-322 FINTEPLA (FENFLURAMINE) SOLUTION [UCB, INC.] 14 Current NDC, Legacy NDC, 4 package rows 20250418_e88f360e-33ad-4cd6-b2de-5ef885857c5d.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 Marketing start Marketing end Sample Exclude flag Status 43376-322-30 43376032230 1 BOTTLE, PLASTIC in 1 CARTON (43376-322-30) / 30 mL in 1 BOTTLE, PLASTIC 2020-07-15 0000-00-00 No No Current 43376-322-36 43376032236 1 BOTTLE, PLASTIC in 1 CARTON (43376-322-36) / 360 mL in 1 BOTTLE, PLASTIC 2020-07-15 0000-00-00 No No Current