Sevelamer Carbonate

Product NDC: 71335-3021
11-digit product format: 713353021
Labeler code: 71335
Product ID: 71335-3021_5c329e0c-2108-4e78-9cfb-46a153a7319d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sevelamer Carbonate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA206100
Marketing category: ANDA
Marketing start: 2023-04-19
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

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-3021		D	Discontinued by firm	2026-08-17
excluded package	package	71335-3021	71335-3021-1	D	Discontinued by firm	2026-08-17
excluded package	package	71335-3021	71335-3021-2	D	Discontinued by firm	2026-08-17
excluded package	package	71335-3021	71335-3021-3	D	Discontinued by firm	2026-08-17

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
A206100-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2023-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206100-001	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.

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	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206100-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2023-04-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206100-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206100-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206100-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206100-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206100-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206100-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206100-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206100-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206100-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206100-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206100-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206100-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206100-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206100-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206100-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206100-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206100-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206100-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206100-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206100-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206100-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206100-001	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206100-001	AB	1	`a50c72e98297…`

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
71335-3021-1	Sevelamer Carbonate	50 in 1 BOTTLE	TABLET, FILM COATED	50	100
71335-3021-2	Sevelamer Carbonate	90 in 1 BOTTLE	TABLET, FILM COATED	90	100
71335-3021-3	Sevelamer Carbonate	100 in 1 BOTTLE	TABLET, FILM COATED	100	100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-3021-1	EA - Each	71335-3021	8f2c9f47-136d-4958-b5ea-dacd0a48484c	1	2026-01-08
71335-3021-2	EA - Each	71335-3021	77a47e2e-f304-4da5-bf58-ea038ebff4a0	1	2026-01-08
71335-3021-3	EA - Each	71335-3021	061eb975-07ea-4572-844a-7dcdd46d8a8e	1	2026-01-08

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sevelamer Carbonate	SEVELAMER CARBONATE	Macleods Pharmaceuticals Limited	4c927d50-34a6-499b-b1c2-924d4eb73987	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206100 application number: ANDA206100
Sevelamer Carbonate	SEVELAMER CARBONATE	Bryant Ranch Prepack	462a11b9-78a3-4d8b-ae5d-3d6528e4d743	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206100 application number: ANDA206100

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	26307350-69bb-40c9-9d5b-e0be2c11d0df	100
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	26307350-69bb-40c9-9d5b-e0be2c11d0df	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-3021-1	71335302101	50 TABLET, FILM COATED in 1 BOTTLE (71335-3021-1)	2025-12-04	No	No	Historical
71335-3021-2	71335302102	90 TABLET, FILM COATED in 1 BOTTLE (71335-3021-2)	2025-12-04	No	No	Historical
71335-3021-3	71335302103	100 TABLET, FILM COATED in 1 BOTTLE (71335-3021-3)	2025-12-04	No	No	Historical