Sevelamer Carbonate

Product NDC: 65162-058
11-digit product format: 651620058
Labeler code: 65162
Product ID: 65162-058_53f81fb7-7bbc-430f-a2e4-841b58e2cb7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sevelamer Carbonate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA207288
Marketing category: ANDA
Marketing start: 2017-11-28
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
A207288-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207288-001	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	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207288-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-11-28	`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	A207288-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207288-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207288-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207288-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207288-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207288-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207288-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207288-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207288-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207288-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207288-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207288-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207288-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207288-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207288-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207288-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207288-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207288-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207288-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207288-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207288-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207288-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207288-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207288-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207288-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207288-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207288-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207288-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207288-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207288-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207288-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207288-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207288-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207288-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207288-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207288-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207288-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207288-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207288-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207288-001	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
94d8cfb1-ff2a-4956-8954-17635ac505d9	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	SPL version
65162-058-03	Sevelamer Carbonate	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
65162-058-06	Sevelamer Carbonate	60 in 1 BOTTLE	TABLET, FILM COATED	60	8
65162-058-09	Sevelamer Carbonate	90 in 1 BOTTLE	TABLET, FILM COATED	90	8
65162-058-11	Sevelamer Carbonate	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	8
65162-058-27	Sevelamer Carbonate	270 in 1 BOTTLE	TABLET, FILM COATED	270	8
65162-058-50	Sevelamer Carbonate	500 in 1 BOTTLE	TABLET, FILM COATED	500	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-058-27	EA - Each	65162-058	de4c772c-b65e-43d1-bee7-d595c437eaae	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-058	SEVELAMER CARBONATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]	8	Current NDC, Legacy NDC, 6 package rows	20240206_94d8cfb1-ff2a-4956-8954-17635ac505d9.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sevelamer Carbonate	SEVELAMER CARBONATE	AvPAK	7f701cb4-3089-375f-e053-2991aa0a51b9	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207288 application number: ANDA207288
Sevelamer Carbonate	SEVELAMER CARBONATE	Precision Dose, Inc.	09b5e422-18c9-49dc-be3d-5d24648184af	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207288 application number: ANDA207288
Sevelamer Carbonate	SEVELAMER CARBONATE	Amneal Pharmaceuticals LLC	94d8cfb1-ff2a-4956-8954-17635ac505d9	2023-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207288 application number: ANDA207288 ndc (product): 65162-058

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	94d8cfb1-ff2a-4956-8954-17635ac505d9	8
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	94d8cfb1-ff2a-4956-8954-17635ac505d9	8
749206	sevelamer carbonate 800 MG Oral Tablet	PSN	7f701cb4-3089-375f-e053-2991aa0a51b9	5
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	7f701cb4-3089-375f-e053-2991aa0a51b9	5
749206	sevelamer carbonate 800 MG Oral Tablet	PSN	09b5e422-18c9-49dc-be3d-5d24648184af	4
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	09b5e422-18c9-49dc-be3d-5d24648184af	4
749206	sevelamer carbonate 800 MG Oral Tablet	PSN	90caaf0e-de31-48bc-8286-c02ef380e8b2	2
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	90caaf0e-de31-48bc-8286-c02ef380e8b2	2
749206	sevelamer carbonate 800 MG Oral Tablet	PSN	852938de-6381-4466-84ee-685d2005ff2a	1
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	852938de-6381-4466-84ee-685d2005ff2a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-058-03	65162005803	30 TABLET, FILM COATED in 1 BOTTLE (65162-058-03)	2023-07-13		No	No	Current
65162-058-06	65162005806	60 TABLET, FILM COATED in 1 BOTTLE (65162-058-06)	2023-07-13		No	No	Current
65162-058-09	65162005809	90 TABLET, FILM COATED in 1 BOTTLE (65162-058-09)	2017-11-28	0000-00-00	No	No	Current
65162-058-11	65162005811	1000 TABLET, FILM COATED in 1 BOTTLE (65162-058-11)	2017-11-28	0000-00-00	No	No	Current
65162-058-27	65162005827	270 TABLET, FILM COATED in 1 BOTTLE (65162-058-27)	2017-11-28	0000-00-00	No	No	Current
65162-058-50	65162005850	500 TABLET, FILM COATED in 1 BOTTLE (65162-058-50)	2017-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sevelamer Carbonate	AvPAK	2026-01-20	HUMAN PRESCRIPTION DRUG LABEL	5
Sevelamer Carbonate	Precision Dose, Inc.	2025-08-11	HUMAN PRESCRIPTION DRUG LABEL	4
Sevelamer Carbonate	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited	2023-11-05	HUMAN PRESCRIPTION DRUG LABEL	8
Sevelamer Carbonate	REMEDYREPACK INC.	2019-10-31	HUMAN PRESCRIPTION DRUG LABEL	3
Sevelamer Carbonate	Marlex Pharmaceuticals Inc	2018-05-14	HUMAN PRESCRIPTION DRUG LABEL	1
Sevelamer Carbonate	Atlantic Biologicals Corps	2018-03-05	HUMAN PRESCRIPTION DRUG LABEL	2