SEVELAMER CARBONATE

Product NDC: 69680-143
Requested package NDC: 69680-143-95
11-digit product format: 696800143
Labeler code: 69680
Product ID: 69680-143_56ec6273-334f-4b70-ad1e-fd98255a55a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SEVELAMER CARBONATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Vitruvias Therapeutics
Application: ANDA212970
Marketing category: ANDA
Marketing start: 2021-02-15
Marketing end: 0000-00-00
Substance: SEVELAMER CARBONATE
Active strength: 800 mg/1
Pharmacologic classes: Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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	69680-143	69680-143-95	D	Discontinued by firm		2026-08-17

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 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
A212970-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET / ORAL			2020-04-09

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212970-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212970-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212970-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212970-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212970-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212970-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212970-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212970-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212970-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212970-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212970-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212970-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212970-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212970-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212970-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212970-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212970-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212970-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212970-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69680-143-95	EA - Each	69680-143	d2656ed4-c199-419d-a50f-6593032da4d7	1	2021-04-08

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
Sevelamer Carbonate	SEVELAMER CARBONATE	Marp Pharma	515ae758-ccba-5758-e063-6394a90a315b	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212970 application number: ANDA212970
SEVELAMER CARBONATE	SEVELAMER CARBONATE	INSIGNAMEDEX LLC	51ce2ed6-3acf-a6ea-e063-6294a90a21aa	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212970 application number: ANDA212970
REVENLA	SEVELAMER CARBONATE	INSIGNAMEDEX LLC	5167a163-c142-b73b-e063-6294a90abd49	2026-05-09		Exact identifier application applno (ANDA): 212970 application number: ANDA212970

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9YCX42I8IU	SEVELAMER CARBONATE	845273-93-0	SEVELAMER CARBONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69680-143-95	69680014395	270 TABLET, FILM COATED in 1 BOTTLE (69680-143-95)	2021-02-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SEVELAMER CARBONATE	Vitruvias Therapeutics \| Anxin Pharma Inc. \| Haimen Pharma Inc.	2022-05-31	HUMAN PRESCRIPTION DRUG LABEL	3