Sevelamer Carbonate

Product NDC: 24979-186
11-digit product format: 249790186
Labeler code: 24979
Product ID: 24979-186_ddf1d2bb-b32a-4fb1-9e0e-1b3047c9b448
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sevelamer Carbonate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: TWi Pharmaceuticals, Inc.
Application: ANDA200959
Marketing category: ANDA
Marketing start: 2019-09-30
Marketing end: 2026-11-30
Substance: SEVELAMER CARBONATE
Active strength: 800 mg/1
Pharmacologic classes: Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag: No
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
A200959-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2018-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200959-001	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	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200959-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2018-03-20	`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	A200959-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200959-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200959-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200959-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200959-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200959-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200959-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200959-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200959-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200959-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200959-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200959-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200959-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200959-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200959-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200959-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200959-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200959-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200959-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200959-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200959-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200959-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200959-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200959-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200959-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200959-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200959-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200959-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200959-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200959-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200959-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200959-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200959-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200959-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200959-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200959-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200959-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200959-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200959-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200959-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sevelamer Carbonate

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
05b076d9-6516-4538-8e05-9709a677ed2f	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
86e7ef73-ca63-701e-e952-6c80aa5122b8	Product name	9	20210309
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24979-186-46	Sevelamer Carbonate	270 in 1 BOTTLE	TABLET, FILM COATED	270		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24979-186-46	EA - Each	24979-186	afbabde0-8311-4399-9076-4147750b6046	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24979-186	SEVELAMER CARBONATE TABLET, FILM COATED [TWI PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240824_05b076d9-6516-4538-8e05-9709a677ed2f.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	AvKARE	41890246-efa5-524a-e063-6294a90a5ad9	2025-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200959 application number: ANDA200959
Sevelamer Carbonate	SEVELAMER CARBONATE	Westminster Pharmaceuticals, LLC	45a955e9-94ac-48db-838c-74934eae245b	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200959 application number: ANDA200959
Sevelamer Carbonate	SEVELAMER CARBONATE	TWi Pharmaceuticals, Inc.	05b076d9-6516-4538-8e05-9709a677ed2f	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200959 application number: ANDA200959 ndc (product): 24979-186
Sevelamer Carbonate	SEVELAMER CARBONATE	Proficient Rx LP	ee9da697-2d55-48e5-8e03-c64c8aaf1fb8	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200959 application number: ANDA200959

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	05b076d9-6516-4538-8e05-9709a677ed2f	4
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	05b076d9-6516-4538-8e05-9709a677ed2f	4
749206	sevelamer carbonate 800 MG Oral Tablet	PSN	ee9da697-2d55-48e5-8e03-c64c8aaf1fb8	3
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	ee9da697-2d55-48e5-8e03-c64c8aaf1fb8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24979-186-46	24979018646	270 TABLET, FILM COATED in 1 BOTTLE (24979-186-46)	2019-09-30	2026-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sevelamer Carbonate	TWi Pharmaceuticals, Inc. \| TWi Pharmaceuticals, Inc. Zhongli Plant \| Bora Pharmaceutical Laboratories Inc. \| Apace Packaging LLC \| Formosa Laboratories, Inc	2024-08-21	HUMAN PRESCRIPTION DRUG LABEL	4
Sevelamer Carbonate	Proficient Rx LP	2024-05-01	HUMAN PRESCRIPTION DRUG LABEL	3