Sevelamer carbonate

Product NDC: 67787-407
Requested package NDC: 67787-407-27
11-digit product format: 677870407
Labeler code: 67787
Product ID: 67787-407_2a1c69d0-6ef6-4c0e-b32b-fd8f2dae5983
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SEVELAMER CARBONATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: InvaGen Pharmaceuticals Inc.
Application: ANDA203860
Marketing category: ANDA
Marketing start: 2017-10-26
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: 2020-12-31
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	67787-407	67787-407-27	I	Inactivated by FDA		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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A203860-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A203860-001	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203860-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203860-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203860-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203860-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203860-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203860-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203860-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203860-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203860-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203860-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203860-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203860-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203860-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203860-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203860-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203860-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203860-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203860-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203860-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203860-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203860-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203860-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203860-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203860-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203860-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203860-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203860-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203860-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203860-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203860-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203860-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203860-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203860-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203860-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203860-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203860-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203860-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203860-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203860-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203860-001	AB	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67787-407-27	2024-01-30	C162847	48780-1	1030e365-5077-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use SEVELAMER CARBONATE TABLETS safely and effectively. See full prescribing information for SEVELAMER CARBONATE TABLETS. SEVELAMER CARBONATE tablets, film coated for oral use Initial U.S. Approval: 2000
67787-407-30	2024-01-30	C162847	48780-1	1030e365-5077-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use SEVELAMER CARBONATE TABLETS safely and effectively. See full prescribing information for SEVELAMER CARBONATE TABLETS. SEVELAMER CARBONATE tablets, film coated for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67787-407-27	Sevelamer carbonate	270 in 1 BOTTLE	TABLET, FILM COATED	270		1
67787-407-30	Sevelamer carbonate	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67787-407	SEVELAMER CARBONATE TABLET, FILM COATED [INVAGEN PHARMACEUTICALS INC.]	1	Legacy NDC, 2 package rows	20171027_40bc25f8-c4f3-4e3a-b120-05adb40e5483.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sevelamer carbonate	SEVELAMER CARBONATE	Cipla USA Inc.	134f32c1-b5d5-44d0-9da5-85033e99320a	2023-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203860 application number: ANDA203860
Sevelamer carbonate	SEVELAMER CARBONATE	Exelan Pharmaceuticals Inc.	f8947f65-57be-4af7-b0e7-17666f496d01	2020-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203860 application number: ANDA203860
Sevelamer carbonate	SEVELAMER CARBONATE	Cipla USA Inc.	f63450bd-d075-4810-a277-e8bc41e4a5af	2018-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203860 application number: ANDA203860
Sevelamer carbonate	SEVELAMER CARBONATE	Exelan Pharmaceuticals Inc.	568b8558-6117-4c2f-aabf-86e567b38863	2018-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203860 application number: ANDA203860

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	40bc25f8-c4f3-4e3a-b120-05adb40e5483	1
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	40bc25f8-c4f3-4e3a-b120-05adb40e5483	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67787-407-27	67787040727	270 TABLET, FILM COATED in 1 BOTTLE (67787-407-27)	2017-10-26	0000-00-00	No	No	Current