Home NDC 16729-342 FINGOLIMOD HYDROCHLORIDE
Product NDC 16729-342
11-digit product format 167290342
Labeler code 16729
Product ID 16729-342_4148bb57-7d2c-1724-e063-6294a90a34fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FINGOLIMOD HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler Accord Healthcare Inc.
Application ANDA207991
Marketing category ANDA
Marketing start 2022-10-18
Substance FINGOLIMOD HYDROCHLORIDE
Active strength .5 mg/1
Pharmacologic classes Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207991-001 FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207991-001 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.
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 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207991-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-10-28 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A207991-001 PC 2023-03-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207991-001 PC 2023-03-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207991-001 PC 2023-03-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207991-001 PC 2023-03-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207991-001 PC 2023-03-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207991-001 PC 2023-03-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207991-001 PC 2023-03-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207991-001 PC 2023-03-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207991-001 PC 2023-03-20 f41ea6bd6efb…
Additional Listing Data#
Finished product Yes
Brand name base FINGOLIMOD HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FINGOLIMOD HYDROCHLORIDE .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G926EC510T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012895 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 16729-342-10 FINGOLIMOD HYDROCHLORIDE 30 in 1 BOTTLE CAPSULE 30 5 16729-342-15 FINGOLIMOD HYDROCHLORIDE 90 in 1 BOTTLE CAPSULE 90 5 16729-342-17 FINGOLIMOD HYDROCHLORIDE 1000 in 1 BOTTLE CAPSULE 1000 5 16729-342-87 FINGOLIMOD HYDROCHLORIDE 7 in 1 CARTON CAPSULE 7 5 16729-342-88 FINGOLIMOD HYDROCHLORIDE 28 in 1 CARTON CAPSULE 28 5 16729-342-89 FINGOLIMOD HYDROCHLORIDE 7 in 1 BOTTLE CAPSULE 7 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-342 FINGOLIMOD HYDROCHLORIDE CAPSULE [ACCORD HEALTHCARE INC.] 4 Current NDC, Legacy NDC, 6 package rows 20240221_65e59a51-c9c2-47b4-84fc-e0f8879eb26c.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 16729-342-10 16729034210 30 CAPSULE in 1 BOTTLE (16729-342-10) 30 capsule 2022-10-18 0000-00-00 No No Current 16729-342-15 16729034215 90 in 1 BOTTLE Historical 16729-342-17 16729034217 1000 in 1 BOTTLE Historical 16729-342-87 16729034287 7 in 1 CARTON Historical 16729-342-88 16729034288 28 in 1 CARTON Historical 16729-342-89 16729034289 7 in 1 BOTTLE Historical