Home NDC 58468-0220 Cerdelga
Product NDC 58468-0220
11-digit product format 584680220
Labeler code 58468
Product ID 58468-0220_e71b0b39-5a29-4e38-8500-55b6d1f48543
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eliglustat
Dosage form CAPSULE
Route ORAL
Labeler Genzyme Corporation
Application NDA205494
Marketing category NDA
Marketing start 2014-09-03
Substance ELIGLUSTAT
Active strength 84 mg/1
Pharmacologic classes Cytochrome P450 2D6 Inhibitors [MoA], Glucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
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 N205494-001 CERDELGA ELIGLUSTAT TARTRATE EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N205494-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205494-001 7196205 2026-06-26 Drug substance 2014-10-21 N205494-001 11458119 2030-11-24 Drug substance, Drug product 2022-11-02 N205494-001 10888547 2031-01-31 U-3042 2021-01-21 N205494-001 10888547 2031-01-31 U-3043 2021-01-21 N205494-001 12465586 2032-06-05 U-3042 2025-12-05 N205494-001 12465586 2032-06-05 U-3043 2025-12-05 N205494-001 10888544 2038-12-13 U-3040 2021-01-21 N205494-001 10888544 2038-12-13 U-3041 2021-01-21
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 · 42 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 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL RLD, RS 2014-08-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL RLD, RS 2014-08-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL RLD, RS 2014-08-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL RLD, RS 2014-08-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL RLD, RS 2014-08-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL RLD, RS 2014-08-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL RLD, RS 2014-08-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL RLD, RS 2014-08-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205494-001 CERDELGA EQ 84MG BASE CAPSULE / ORAL AB RLD, RS 2014-08-19 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 7 · 274 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N205494-001 7196205 2026-06-26 Drug substance 2014-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205494-001 11458119 2030-11-24 Drug substance, Drug product 2022-11-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205494-001 10888547 2031-01-31 U-3042 2021-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205494-001 10888547 2031-01-31 U-3043 2021-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205494-001 12465586 2032-06-05 U-3042 2025-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205494-001 12465586 2032-06-05 U-3043 2025-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205494-001 10888544 2038-12-13 U-3041 2021-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205494-001 10888544 2038-12-13 U-3040 2021-01-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205494-001 7196205 2026-06-26 Drug substance 2014-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205494-001 11458119 2030-11-24 Drug substance, Drug product 2022-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205494-001 10888547 2031-01-31 U-3042 2021-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205494-001 10888547 2031-01-31 U-3043 2021-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205494-001 12465586 2032-06-05 U-3042 2025-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205494-001 12465586 2032-06-05 U-3043 2025-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205494-001 10888544 2038-12-13 U-3041 2021-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205494-001 10888544 2038-12-13 U-3040 2021-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205494-001 7196205 2026-06-26 Drug substance 2014-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205494-001 11458119 2030-11-24 Drug substance, Drug product 2022-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205494-001 10888547 2031-01-31 U-3042 2021-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205494-001 10888547 2031-01-31 U-3043 2021-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205494-001 12465586 2032-06-05 U-3042 2025-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205494-001 12465586 2032-06-05 U-3043 2025-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205494-001 10888544 2038-12-13 U-3041 2021-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205494-001 10888544 2038-12-13 U-3040 2021-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205494-001 7196205 2026-06-26 Drug substance 2014-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205494-001 11458119 2030-11-24 Drug substance, Drug product 2022-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205494-001 10888547 2031-01-31 U-3042 2021-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205494-001 10888547 2031-01-31 U-3043 2021-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205494-001 10888544 2038-12-13 U-3041 2021-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205494-001 10888544 2038-12-13 U-3040 2021-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205494-001 7196205 2026-06-26 Drug substance 2014-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205494-001 11458119 2030-11-24 Drug substance, Drug product 2022-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205494-001 10888547 2031-01-31 U-3042 2021-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205494-001 10888547 2031-01-31 U-3043 2021-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205494-001 10888544 2038-12-13 U-3041 2021-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205494-001 10888544 2038-12-13 U-3040 2021-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205494-001 7196205 2026-06-26 Drug substance 2014-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205494-001 11458119 2030-11-24 Drug substance, Drug product 2022-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205494-001 10888547 2031-01-31 U-3042 2021-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205494-001 10888547 2031-01-31 U-3043 2021-01-21 b8a1b40f171c…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Cerdelga
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELIGLUSTAT 84 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DR40J4WA67 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1547225 Internal RxNorm lookup 1547231 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 58468-0220-1 Cerdelga 14 in 1 BLISTER PACK CAPSULE 14 13 58468-0220-1 Cerdelga 4 in 1 CARTON CAPSULE 4 13 58468-0220-2 Cerdelga 14 in 1 BLISTER PACK CAPSULE 14 13 58468-0220-2 Cerdelga 1 in 1 CARTON CAPSULE 1 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58468-0220 CERDELGA (ELIGLUSTAT) CAPSULE [GENZYME CORPORATION] 13 Current NDC, Legacy NDC, 4 package rows 20240310_819f828a-b888-4e46-83fc-94d774a28a83.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 58468-0220-1 58468022001 4 BLISTER PACK in 1 CARTON (58468-0220-1) / 14 CAPSULE in 1 BLISTER PACK 4 blister pack 2014-09-03 0000-00-00 No No Current 58468-0220-2 58468022002 1 BLISTER PACK in 1 CARTON (58468-0220-2) / 14 CAPSULE in 1 BLISTER PACK 1 blister pack 2014-09-03 0000-00-00 No No Current