Sevelamer Hydrochloride

Product NDC: 0955-1048
11-digit product format: 009551048
Labeler code: 0955
Product ID: 0955-1048_b5d5e078-07d1-41bd-90ae-581497782412
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sevelamer Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Winthrop U.S, a business of sanofi-aventis U.S. LLC
Application: NDA021179
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-02-13
Marketing end: 0000-00-00
Substance: SEVELAMER HYDROCHLORIDE
Active strength: 800 mg/1
Pharmacologic classes: Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0955-1048		D	Discontinued by firm		2026-08-03
excluded package	package	0955-1048	0955-1048-18	D	Discontinued by firm		2026-08-03

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
N021179-001	RENAGEL	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	RLD	2000-07-12
N021179-002	RENAGEL	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021179-001	AB
N021179-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`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	N021179-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021179-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021179-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021179-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021179-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021179-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021179-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021179-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021179-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021179-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021179-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021179-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021179-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021179-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021179-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021179-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021179-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021179-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021179-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021179-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021179-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021179-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021179-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021179-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021179-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021179-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021179-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021179-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021179-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021179-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021179-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021179-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021179-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021179-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021179-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021179-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021179-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021179-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021179-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021179-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021179-001	6733780	2020-10-18	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021179-002	6733780	2020-10-18	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021179-001	6733780	2020-10-18	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021179-002	6733780	2020-10-18	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021179-001	6733780	2020-10-18	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021179-002	6733780	2020-10-18	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021179-001	6733780	2020-10-18	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021179-002	6733780	2020-10-18	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021179-001	6733780	2020-10-18	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021179-002	6733780	2020-10-18	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021179-001	6733780	2020-10-18	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021179-002	6733780	2020-10-18	Drug product	`ea99ee380514…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0955-1048-18	EA - Each	0955-1048	bc550292-63e0-4bd2-b408-43690caacae5	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0955-1048	SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [WINTHROP U.S.]	16	Legacy NDC	20240731_5a76bd76-a6cc-46f1-bb58-660566eaec06.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0955-1048-18	00955104818	180 TABLET, FILM COATED in 1 BOTTLE (0955-1048-18)	2019-02-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sevelamer Hydrochloride	Sanofi-Aventis U.S. LLC \| HVL Pharma UK Limited \| Reed-Lane, Inc. \| Genzyme Ireland Limited \| Eurofins Biopharma Product Testing Ireland Limited \| Sanofi Winthrop Industrie	2025-11-25	HUMAN PRESCRIPTION DRUG LABEL	19