LOKELMA

Product NDC: 0310-1110
Requested package NDC: 0310-1110-98
11-digit product format: 003101110
Labeler code: 0310
Product ID: 0310-1110_e97b97a9-6ad1-4b47-a5be-fefd7be47c23
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sodium zirconium cyclosilicate
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA207078
Marketing category: NDA
Marketing start: 2018-09-04
Substance: SODIUM ZIRCONIUM CYCLOSILICATE
Active strength: 10 g/10g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0310-1110	0310-1110-98	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207078-001	M-261	2023-04-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207078-001	NCE	2023-05-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207078-002	M-261	2023-04-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207078-002	NCE	2023-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207078-001	M-261	2023-04-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207078-001	NCE	2023-05-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207078-002	M-261	2023-04-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207078-002	NCE	2023-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207078-001	M-261	2023-04-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207078-001	NCE	2023-05-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207078-002	M-261	2023-04-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207078-002	NCE	2023-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207078-001	NCE	2023-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207078-002	NCE	2023-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207078-001	M-261	2023-04-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207078-001	NCE	2023-05-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207078-002	M-261	2023-04-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207078-002	NCE	2023-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207078-001	M-261	2023-04-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207078-001	NCE	2023-05-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207078-002	M-261	2023-04-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207078-002	NCE	2023-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207078-001	M-261	2023-04-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207078-001	NCE	2023-05-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207078-002	M-261	2023-04-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207078-002	NCE	2023-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207078-001	M-261	2023-04-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N207078-001	NCE	2023-05-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N207078-002	M-261	2023-04-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N207078-002	NCE	2023-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207078-001	M-261	2023-04-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207078-001	NCE	2023-05-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207078-002	M-261	2023-04-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207078-002	NCE	2023-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207078-001	M-261	2023-04-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207078-001	NCE	2023-05-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207078-002	M-261	2023-04-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207078-002	NCE	2023-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207078-001	NCE	2023-05-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207078-002	NCE	2023-05-18	`3f01610625f2…`

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	10 g/10g

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2047633	Internal RxNorm lookup
2047639	Internal RxNorm lookup
2047642	Internal RxNorm lookup
2053927	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
90bf8e28-748d-4e4b-a19f-9cf483370eff	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e5a8f09f-bf3b-4b64-a5a6-c14b92cb0dfc	Product name	1	20230809

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0310-1110-01	LOKELMA	10 g in 1 PACKET	POWDER, FOR SUSPENSION	10	28
0310-1110-30	LOKELMA	30 in 1 BOX	POWDER, FOR SUSPENSION	30	28
0310-1110-39	LOKELMA	11 in 1 BOX	POWDER, FOR SUSPENSION	11	28
0310-1110-91	LOKELMA	10 g in 1 PACKET	POWDER, FOR SUSPENSION	10	28
0310-1110-93	LOKELMA	3 in 1 BOX	POWDER, FOR SUSPENSION	3	28
0310-1110-94	LOKELMA	11 in 1 BOX	POWDER, FOR SUSPENSION	11	28
0310-1110-98	LOKELMA	30 in 1 BOX	POWDER, FOR SUSPENSION	30	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-1110-01	EA - Each	0310-1110	5fc5445c-17d1-4c7c-ad80-106fa61cde7f	1	2018-09-05
0310-1110-30	EA - Each	0310-1110	ce05dd26-736f-46d9-90ec-a012ccb6ea30	1	2018-09-05
0310-1110-39	EA - Each	0310-1110	bf60586d-683d-439e-8a6f-5a8df3ae5624	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0310-1110	LOKELMA (SODIUM ZIRCONIUM CYCLOSILICATE) POWDER, FOR SUSPENSION [ASTRAZENECA PHARMACEUTICALS LP]	28	Current NDC, Legacy NDC, 7 package rows	20250213_90bf8e28-748d-4e4b-a19f-9cf483370eff.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	A-S Medication Solutions	8833d6e6-33ab-4ea9-b78f-3ec30a904ef8	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207078 application number: NDA207078
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	AstraZeneca Pharmaceuticals LP	90bf8e28-748d-4e4b-a19f-9cf483370eff	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207078 application number: NDA207078 ndc (package): 0310-1110-98 ndc (product): 0310-1110 ndc11 (package): 00310111098
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	A-S Medication Solutions	7f7ed64d-8480-4143-a207-29c24a0b9363	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207078 application number: NDA207078

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D652ZWF066	SODIUM ZIRCONIUM CYCLOSILICATE	17141-74-1	SODIUM ZIRCONIUM CYCLOSILICATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2053927	Lokelma 10 GM Powder for Oral Suspension	PSN	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2047639	LOKELMA 5 GM Powder for Oral Suspension	PSN	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2047642	sodium zirconium cyclosilicate 10 GM Powder for Oral Suspension	PSN	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2047633	sodium zirconium cyclosilicate 5 GM Powder for Oral Suspension	PSN	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2053927	sodium zirconium cyclosilicate 10000 MG Powder for Oral Suspension [Lokelma]	SBD	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2047639	sodium zirconium cyclosilicate 5000 MG Powder for Oral Suspension [Lokelma]	SBD	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2047642	sodium zirconium cyclosilicate 10000 MG Powder for Oral Suspension	SCD	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2047633	sodium zirconium cyclosilicate 5000 MG Powder for Oral Suspension	SCD	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2053927	Lokelma 10 GM Powder for Oral Suspension	SY	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2053927	Lokelma 10000 MG Powder for Oral Suspension	SY	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2047639	Lokelma 5 GM Powder for Oral Suspension	SY	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2047639	Lokelma 5000 MG Powder for Oral Suspension	SY	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2047642	sodium zirconium cyclosilicate 10 GM Powder for Oral Suspension	SY	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2047633	sodium zirconium cyclosilicate 5 GM Powder for Oral Suspension	SY	90bf8e28-748d-4e4b-a19f-9cf483370eff	28
2053927	Lokelma 10 GM Powder for Oral Suspension	PSN	8833d6e6-33ab-4ea9-b78f-3ec30a904ef8	8
2047642	sodium zirconium cyclosilicate 10 GM Powder for Oral Suspension	PSN	8833d6e6-33ab-4ea9-b78f-3ec30a904ef8	8
2053927	sodium zirconium cyclosilicate 10000 MG Powder for Oral Suspension [Lokelma]	SBD	8833d6e6-33ab-4ea9-b78f-3ec30a904ef8	8
2047642	sodium zirconium cyclosilicate 10000 MG Powder for Oral Suspension	SCD	8833d6e6-33ab-4ea9-b78f-3ec30a904ef8	8
2053927	Lokelma 10 GM Powder for Oral Suspension	SY	8833d6e6-33ab-4ea9-b78f-3ec30a904ef8	8
2053927	Lokelma 10000 MG Powder for Oral Suspension	SY	8833d6e6-33ab-4ea9-b78f-3ec30a904ef8	8
2047642	sodium zirconium cyclosilicate 10 GM Powder for Oral Suspension	SY	8833d6e6-33ab-4ea9-b78f-3ec30a904ef8	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-1110-98	00310111098	30 PACKET in 1 BOX (0310-1110-98) > 10 g in 1 PACKET (0310-1110-91)	30 packet	2018-09-04	2021-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LOKELMA	A-S Medication Solutions	2026-03-26	HUMAN PRESCRIPTION DRUG LABEL	8
LOKELMA	AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	2024-02-08	HUMAN PRESCRIPTION DRUG LABEL	28