Sevelamer Carbonate

Product NDC: 65862-921
11-digit product format: 658620921
Labeler code: 65862
Product ID: 65862-921_761597e6-1a2e-48e7-b657-c3fa781b4f6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sevelamer Carbonate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA207179
Marketing category: ANDA
Marketing start: 2017-07-17
Substance: SEVELAMER CARBONATE
Active strength: 800 mg/1
Pharmacologic classes: Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A207179-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	RS	2017-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207179-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	RS	2017-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207179-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-07-17	`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	A207179-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207179-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207179-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207179-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207179-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207179-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207179-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207179-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207179-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207179-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207179-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207179-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207179-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207179-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207179-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207179-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207179-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207179-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207179-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207179-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207179-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207179-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207179-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207179-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207179-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207179-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207179-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207179-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207179-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207179-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207179-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207179-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207179-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207179-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207179-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207179-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207179-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207179-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207179-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207179-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sevelamer Carbonate
Listing expiration: 2026-12-31

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
ab0cd45f-0c4b-4ce7-bf8e-5f98d43feaab	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
86e7ef73-ca63-701e-e952-6c80aa5122b8	Product name	9	20210309
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-921-18	Sevelamer Carbonate	180 in 1 BOTTLE	TABLET, FILM COATED	180	11
65862-921-27	Sevelamer Carbonate	270 in 1 BOTTLE	TABLET, FILM COATED	270	11
65862-921-30	Sevelamer Carbonate	30 in 1 BOTTLE	TABLET, FILM COATED	30	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-921-27	EA - Each	65862-921	d8941fa7-5533-4f5b-a980-7ff16e291307	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-921	SEVELAMER CARBONATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	11	Current NDC, Legacy NDC, 3 package rows	20240406_ab0cd45f-0c4b-4ce7-bf8e-5f98d43feaab.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sevelamer Carbonate	SEVELAMER CARBONATE	ATLANTIC BIOLOGICALS CORP.	07b709fd-a2a1-4ff1-ad19-827d38e84562	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207179 application number: ANDA207179
Sevelamer Carbonate	SEVELAMER CARBONATE	Cardinal Health 107, LLC	61d073ec-51a4-48c7-8762-25fdd00fe6ac	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207179 application number: ANDA207179
Sevelamer Carbonate	SEVELAMER CARBONATE	NCS HealthCare of KY, LLC dba Vangard Labs	ccfde4dd-b258-4baf-995b-a24bed8c84d7	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207179 application number: ANDA207179
Sevelamer Carbonate	SEVELAMER CARBONATE	American Health Packaging	bd0a89ab-91c4-42b3-aa88-1e3295d0d344	2024-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207179 application number: ANDA207179
Sevelamer Carbonate	SEVELAMER CARBONATE	NorthStar Rx LLC	9b4d0720-f4e7-4b4f-affc-57ce8bb0b722	2024-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207179 application number: ANDA207179
Sevelamer Carbonate	SEVELAMER CARBONATE	Aurobindo Pharma Limited	ab0cd45f-0c4b-4ce7-bf8e-5f98d43feaab	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207179 application number: ANDA207179 ndc (product): 65862-921

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	ab0cd45f-0c4b-4ce7-bf8e-5f98d43feaab	11
749206	sevelamer carbonate 800 MG Oral Tablet	PSN	ccfde4dd-b258-4baf-995b-a24bed8c84d7	11
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	ab0cd45f-0c4b-4ce7-bf8e-5f98d43feaab	11
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	ccfde4dd-b258-4baf-995b-a24bed8c84d7	11
749206	sevelamer carbonate 800 MG Oral Tablet	PSN	bd0a89ab-91c4-42b3-aa88-1e3295d0d344	7
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	bd0a89ab-91c4-42b3-aa88-1e3295d0d344	7
749206	sevelamer carbonate 800 MG Oral Tablet	PSN	07b709fd-a2a1-4ff1-ad19-827d38e84562	5
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	07b709fd-a2a1-4ff1-ad19-827d38e84562	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-921-18	65862092118	180 TABLET, FILM COATED in 1 BOTTLE (65862-921-18)	2017-07-17	0000-00-00	No	No	Current
65862-921-27	65862092127	270 TABLET, FILM COATED in 1 BOTTLE (65862-921-27)	2017-07-17	0000-00-00	No	No	Current
65862-921-30	65862092130	30 TABLET, FILM COATED in 1 BOTTLE (65862-921-30)	2017-07-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sevelamer Carbonate	ATLANTIC BIOLOGICALS CORP.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	5
Sevelamer Carbonate	NCS HealthCare of KY, LLC dba Vangard Labs	2024-08-09	HUMAN PRESCRIPTION DRUG LABEL	11
Sevelamer Carbonate	American Health Packaging	2024-07-30	HUMAN PRESCRIPTION DRUG LABEL	7
Sevelamer Carbonate	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2024-04-04	Human Prescription Drug Label	11
Sevelamer Carbonate	REMEDYREPACK INC.	2019-07-25	HUMAN PRESCRIPTION DRUG LABEL	3