sevelamer hydrochloride

Product NDC: 55154-2647
Requested package NDC: 55154-2647-0
11-digit product format: 551542647
Labeler code: 55154
Product ID: 55154-2647_cd703ad5-7d31-462e-971e-44bd794498ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sevelamer hydrochloride
Dosage form: TABLET, FILM COATED
Route: PARENTERAL
Labeler: Cardinal Health 107, LLC
Application: ANDA204724
Marketing category: ANDA
Marketing start: 2025-02-25
Substance: SEVELAMER HYDROCHLORIDE
Active strength: 800 mg/1
Pharmacologic classes: Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204724-001	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB		2019-02-08
A204724-002	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB		2019-02-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204724-001	AB
A204724-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204724-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204724-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204724-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204724-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204724-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204724-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204724-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204724-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204724-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204724-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204724-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204724-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204724-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204724-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204724-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204724-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204724-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204724-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204724-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204724-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204724-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204724-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204724-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204724-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204724-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204724-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204724-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204724-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204724-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204724-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204724-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204724-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204724-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204724-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204724-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204724-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204724-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204724-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204724-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204724-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: sevelamer hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SEVELAMER HYDROCHLORIDE	800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
GLS2PGI8QG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
857224	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
c13532a7-4c56-4084-839d-3dcfd4dc30f8	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	Strength	SPL version
55154-2647-0	sevelamer hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		2
55154-2647-0	sevelamer hydrochloride	10 in 1 BAG	TABLET, FILM COATED	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-2647	SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]	1	Current NDC, 2 package rows	20250228_c13532a7-4c56-4084-839d-3dcfd4dc30f8.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 Hydrochloride	SEVELAMER HYDROCHLORIDE	American Health Packaging	8830526f-d957-423e-84ea-e4d79346948b	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204724 application number: ANDA204724
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Cardinal Health 107, LLC	c13532a7-4c56-4084-839d-3dcfd4dc30f8	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204724 application number: ANDA204724 ndc (package): 55154-2647-0 ndc (product): 55154-2647 ndc11 (package): 55154264700
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Major Pharmaceuticals	0500034d-458c-42c5-918d-9acd22f0c28b	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204724 application number: ANDA204724
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	2cd6512f-0edd-4a30-a4fa-aa996038633c	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204724 application number: ANDA204724

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GLS2PGI8QG	SEVELAMER HYDROCHLORIDE	152751-57-0	SEVELAMER HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857224	sevelamer HCl 800 MG Oral Tablet	PSN	c13532a7-4c56-4084-839d-3dcfd4dc30f8	2
857224	sevelamer hydrochloride 800 MG Oral Tablet	SCD	c13532a7-4c56-4084-839d-3dcfd4dc30f8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-2647-0	55154264700	10 BLISTER PACK in 1 BAG (55154-2647-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2025-02-25	No	No	Current