SEVELAMER CARBONATE

Product NDC: 87367-266
11-digit product format: 873670266
Labeler code: 87367
Product ID: 87367-266_52693574-1205-8244-e063-6394a90a5e78
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sevelamer Carbonate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: INSIGNAMEDEX LLC
Application: ANDA212970
Marketing category: ANDA
Marketing start: 2026-05-21
Substance: SEVELAMER CARBONATE
Active strength: 800 mg/1
Pharmacologic classes: Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: SEVELAMER CARBONATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SEVELAMER CARBONATE	800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9YCX42I8IU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
749206	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
51ce2ed6-3acf-a6ea-e063-6294a90a21aa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5085f16b-f856-182d-a646-425b62d3f565	Product name	6	20251118
86e7ef73-ca63-701e-e952-6c80aa5122b8	Product name	9	20210309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
87367-266-12	SEVELAMER CARBONATE	270 in 1 BOTTLE	TABLET, FILM COATED	270		2

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 ndc (product): 87367-266
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
749206	sevelamer carbonate 800 MG Oral Tablet	PSN	51ce2ed6-3acf-a6ea-e063-6294a90a21aa	2
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	51ce2ed6-3acf-a6ea-e063-6294a90a21aa	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
87367-266-12	87367026612	270 TABLET, FILM COATED in 1 BOTTLE (87367-266-12)	2026-05-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SEVELAMER CARBONATE - INSIGNAMEDEX LLC \| HAIMEN PHARMA INC.	INSIGNAMEDEX LLC \| HAIMEN PHARMA INC.	2026-05-22	HUMAN PRESCRIPTION DRUG LABEL	2