sevelamer hydrochloride

Product NDC: 68462-447
11-digit product format: 684620447
Labeler code: 68462
Product ID: 68462-447_5b27539f-4664-4a6b-abe4-2abcc7ad2279
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sevelamer hydrochloride
Dosage form: TABLET, FILM COATED
Route: PARENTERAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA204724
Marketing category: ANDA
Marketing start: 2019-02-08
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 1.

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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A204724-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204724-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204724-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204724-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
857216	Internal RxNorm lookup
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
2cd6512f-0edd-4a30-a4fa-aa996038633c	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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	Strength	SPL version
68462-447-18	sevelamer hydrochloride	180 in 1 BOTTLE	TABLET, FILM COATED	180		7
68462-447-30	sevelamer hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-447-18	EA - Each	68462-447	c7169861-139c-444c-84e5-75e151407e89	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-447	SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	6	Current NDC, Legacy NDC, 2 package rows	20240104_2cd6512f-0edd-4a30-a4fa-aa996038633c.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 · 5 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
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 ndc (product): 68462-447
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	NorthStar RxLLC	a229a42a-4d1b-45df-aa77-71f44e0921ee	2025-08-15	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
857216	sevelamer HCl 400 MG Oral Tablet	PSN	2cd6512f-0edd-4a30-a4fa-aa996038633c	7
857224	sevelamer HCl 800 MG Oral Tablet	PSN	2cd6512f-0edd-4a30-a4fa-aa996038633c	7
857216	sevelamer hydrochloride 400 MG Oral Tablet	SCD	2cd6512f-0edd-4a30-a4fa-aa996038633c	7
857224	sevelamer hydrochloride 800 MG Oral Tablet	SCD	2cd6512f-0edd-4a30-a4fa-aa996038633c	7
857224	sevelamer HCl 800 MG Oral Tablet	PSN	8830526f-d957-423e-84ea-e4d79346948b	4
857224	sevelamer hydrochloride 800 MG Oral Tablet	SCD	8830526f-d957-423e-84ea-e4d79346948b	4
857224	sevelamer HCl 800 MG Oral Tablet	PSN	0500034d-458c-42c5-918d-9acd22f0c28b	3
857224	sevelamer hydrochloride 800 MG Oral Tablet	SCD	0500034d-458c-42c5-918d-9acd22f0c28b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-447-18	68462044718	180 TABLET, FILM COATED in 1 BOTTLE (68462-447-18)	2019-02-08	0000-00-00	No	No	Current
68462-447-30	68462044730	30 TABLET, FILM COATED in 1 BOTTLE (68462-447-30)	2019-02-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sevelamer Hydrochloride	American Health Packaging	2026-06-25	HUMAN PRESCRIPTION DRUG LABEL	5
sevelamer hydrochloride	Major Pharmaceuticals	2026-02-13	HUMAN PRESCRIPTION DRUG LABEL	3
sevelamer hydrochloride	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-27	HUMAN PRESCRIPTION DRUG LABEL	7