Home NDC 50090-6502 LOKELMA
Product NDC 50090-6502
11-digit product format 500906502
Labeler code 50090
Product ID 50090-6502_f69e7a3d-5f83-4022-939a-7e373d0b0cdb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium zirconium cyclosilicate
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler A-S Medication Solutions
Application NDA207078
Marketing category NDA
Marketing start 2018-09-04
Substance SODIUM ZIRCONIUM CYCLOSILICATE
Active strength 5 g/5g
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207078-001 LOKELMA SODIUM ZIRCONIUM CYCLOSILICATE 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 N207078-002 LOKELMA SODIUM ZIRCONIUM CYCLOSILICATE 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18
Orange Book patents# Current patent rows page 1 of 1 · 27 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207078-001 10335432 2032-02-10 U-2312 2019-07-25 N207078-001 10398730 2032-02-10 U-2312 2019-10-01 N207078-001 10413569 2032-02-10 Drug substance 2019-10-01 N207078-001 11406662 2032-02-10 Drug substance 2022-09-07 N207078-001 8808750 2032-02-10 U-2312 2018-06-12 N207078-001 9844567 2032-02-10 U-2312 2018-06-12 N207078-001 9861658 2032-02-10 U-2312 2018-06-12 N207078-001 8802152 2032-04-19 Drug substance 2018-06-12 N207078-001 10695365 2033-10-22 Drug substance 2020-07-28 N207078-001 8877255 2033-10-22 Drug substance 2018-06-12 N207078-001 9913860 2033-10-22 U-2312 Drug substance 2019-01-23 N207078-001 10300087 2035-10-14 U-2312 Drug substance 2019-07-25 N207078-001 11738044 2035-10-14 U-2312 2023-09-21 N207078-001 9592253 2035-10-14 U-2312 Drug substance 2018-06-12 N207078-002 10398730 2032-02-10 U-2312 2019-10-01 N207078-002 10413569 2032-02-10 Drug substance 2019-10-01 N207078-002 11406662 2032-02-10 Drug substance 2022-09-07 N207078-002 8808750 2032-02-10 U-2312 2018-06-12 N207078-002 9844567 2032-02-10 U-2312 2018-06-12 N207078-002 9861658 2032-02-10 U-2312 2018-06-12 N207078-002 8802152 2032-04-19 Drug substance 2018-06-12 N207078-002 10695365 2033-10-22 Drug substance 2020-07-28 N207078-002 8877255 2033-10-22 Drug substance 2018-06-12 N207078-002 9913860 2033-10-22 U-2312 Drug substance 2019-01-23 N207078-002 10300087 2035-10-14 U-2312 Drug substance 2019-07-25 N207078-002 11738044 2035-10-14 U-2312 2023-09-21 N207078-002 9592253 2035-10-14 U-2312 Drug substance 2018-06-12
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 · 82 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 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207078-001 LOKELMA 5GM/PACKET FOR SUSPENSION / ORAL RLD 2018-05-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N207078-002 LOKELMA 10GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-18 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 26 · 1,026 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 N207078-001 10335432 2032-02-10 U-2312 2019-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-001 10398730 2032-02-10 U-2312 2019-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-001 10413569 2032-02-10 Drug substance 2019-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-001 11406662 2032-02-10 Drug substance 2022-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-001 8808750 2032-02-10 U-2312 2018-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-001 9844567 2032-02-10 U-2312 2018-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-001 9861658 2032-02-10 U-2312 2018-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-001 8802152 2032-04-19 Drug substance 2018-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-001 10695365 2033-10-22 Drug substance 2020-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-001 8877255 2033-10-22 Drug substance 2018-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-001 9913860 2033-10-22 U-2312 Drug substance 2019-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-001 10300087 2035-10-14 U-2312 Drug substance 2019-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-001 11738044 2035-10-14 U-2312 2023-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-001 9592253 2035-10-14 U-2312 Drug substance 2018-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 10398730 2032-02-10 U-2312 2019-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 10413569 2032-02-10 Drug substance 2019-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 11406662 2032-02-10 Drug substance 2022-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 8808750 2032-02-10 U-2312 2018-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 9844567 2032-02-10 U-2312 2018-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 9861658 2032-02-10 U-2312 2018-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 8802152 2032-04-19 Drug substance 2018-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 10695365 2033-10-22 Drug substance 2020-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 8877255 2033-10-22 Drug substance 2018-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 9913860 2033-10-22 U-2312 Drug substance 2019-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 10300087 2035-10-14 U-2312 Drug substance 2019-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 11738044 2035-10-14 U-2312 2023-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207078-002 9592253 2035-10-14 U-2312 Drug substance 2018-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 10335432 2032-02-10 U-2312 2019-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 10398730 2032-02-10 U-2312 2019-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 10413569 2032-02-10 Drug substance 2019-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 11406662 2032-02-10 Drug substance 2022-09-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 8808750 2032-02-10 U-2312 2018-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 9844567 2032-02-10 U-2312 2018-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 9861658 2032-02-10 U-2312 2018-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 8802152 2032-04-19 Drug substance 2018-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 10695365 2033-10-22 Drug substance 2020-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 8877255 2033-10-22 Drug substance 2018-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 9913860 2033-10-22 U-2312 Drug substance 2019-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 10300087 2035-10-14 U-2312 Drug substance 2019-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207078-001 11738044 2035-10-14 U-2312 2023-09-21 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 88 observed states.
Additional Listing Data#
Finished product Yes
Brand name base LOKELMA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM ZIRCONIUM CYCLOSILICATE 5 g/5g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D652ZWF066 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2047633 Internal RxNorm lookup 2047639 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 50090-6502-0 LOKELMA 5 g in 1 PACKET POWDER, FOR SUSPENSION 5 1 50090-6502-0 LOKELMA 30 in 1 BOX POWDER, FOR SUSPENSION 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6502 LOKELMA (SODIUM ZIRCONIUM CYCLOSILICATE) POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS] 1 Current NDC, 2 package rows 20230601_7f7ed64d-8480-4143-a207-29c24a0b9363.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-6502-0 50090650200 30 PACKET in 1 BOX (50090-6502-0) / 5 g in 1 PACKET 30 packet 2023-05-25 No No Current