Sevelamer Tablets

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-08-12
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 21:10:27

Label at a glance#

ProductSevelamer carbonate

Active ingredientSEVELAMER CARBONATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1520-8

Sevelamer Tablets, 800 mg

270 Tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
749206	sevelamer carbonate 800 MG Oral Tablet	PSN	3
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
SEVELAMER Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
70771-1520-0	Sevelamer carbonate	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	3
70771-1520-2	Sevelamer carbonate	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	3
70771-1520-4	Sevelamer carbonate	10 in 1 CARTON	TABLET, FILM COATED	10	3
70771-1520-8	Sevelamer carbonate	270 in 1 BOTTLE	TABLET, FILM COATED	270	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1520	SEVELAMER CARBONATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	3	Current NDC, Legacy NDC, 4 package rows	20240815_cbdee883-ccc7-4c55-965d-b608a214b375.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

Sevelamer carbonate
SEVELAMER
CASTOR OIL
CROSPOVIDONE (15 MPA.S AT 5%)
DIBUTYL SEBACATE
FERROSOFERRIC OXIDE
HYPROMELLOSE 2910 (15 MPA.S)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE K90
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
TRIACETIN
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1520	70771-1520-8, 70771-1520-0, 70771-1520-2, 70771-1520-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SEVELAMER CARBONATE	9YCX42I8IU	ACTIB
CASTOR OIL	D5340Y2I9G	IACT
CROSPOVIDONE (15 MPA.S AT 5%)	68401960MK	IACT
DIBUTYL SEBACATE	4W5IH7FLNY	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
HYPROMELLOSE 2910 (15 MPA.S)	36SFW2JZ0W	IACT
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
HYPROMELLOSE 2910 (50 MPA.S)	1IVH67816N	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
POVIDONE K90	RDH86HJV5Z	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TRIACETIN	XHX3C3X673	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207759-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2020-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207759-001	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
2026-09-14 22:38:34	2026-08	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207759-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207759-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207759-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207759-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207759-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207759-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207759-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207759-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207759-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207759-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207759-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207759-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207759-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207759-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207759-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207759-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207759-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207759-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207759-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207759-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207759-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207759-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207759-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207759-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207759-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207759-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207759-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207759-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207759-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207759-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207759-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207759-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207759-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207759-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207759-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207759-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207759-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207759-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207759-001	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sevelamer carbonate	SEVELAMER CARBONATE	Zydus Lifesciences Limited	cbdee883-ccc7-4c55-965d-b608a214b375	2024-08-12		Exact identifier ndc (package): 70771-1520-2 ndc (package): 70771-1520-0 ndc (package): 70771-1520-4 ndc (package): 70771-1520-8 ndc (product): 70771-1520 ndc11 (package): 70771152000 ndc11 (package): 70771152002 ndc11 (package): 70771152008 ndc11 (package): 70771152004 spl id: 39b27e86-2261-45f0-bdbf-13edbc8d6310 spl set id: cbdee883-ccc7-4c55-965d-b608a214b375

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.