SEVELAMER CARBONATE

Product NDC: 11788-116
11-digit product format: 117880116
Labeler code: 11788
Product ID: 11788-116_98ce69c6-ff2b-4b2e-988f-5e15d7f774e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SEVELAMER CARBONATE
Dosage form: TABLET
Route: ORAL
Labeler: AiPing Pharmaceutical, Inc.
Application: ANDA215998
Marketing category: ANDA
Marketing start: 2025-12-15
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

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
A215998-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2024-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215998-001	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	A215998-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2024-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215998-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2024-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215998-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2024-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215998-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2024-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215998-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2024-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215998-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2024-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215998-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2024-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215998-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2024-10-24	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215998-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2024-10-24	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215998-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2024-10-24	`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	A215998-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215998-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215998-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215998-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215998-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215998-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215998-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215998-001	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215998-001	AB	1	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215998-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: SEVELAMER CARBONATE
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9YCX42I8IU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
749206	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
0cade89a-38ca-4072-97a0-be09c6e058f4	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
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
11788-116-07	SEVELAMER CARBONATE	270 in 1 BOTTLE	TABLET	270		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11788-116-07	EA - Each	11788-116	a21eef2d-d2e4-48e7-8c68-c22c0fc00e55	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SEVELAMER CARBONATE	SEVELAMER CARBONATE	PD-Rx Pharmaceuticals, Inc.	b72baeeb-b6f5-4fa1-bee8-9eb4bb74dc82	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215998 application number: ANDA215998
SEVELAMER CARBONATE	SEVELAMER CARBONATE	Shandong Xinhua Pharmaceutical Co., Ltd.	f6455fa3-ad53-f6fd-e053-2a95a90a67db	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215998 application number: ANDA215998
SEVELAMER CARBONATE	SEVELAMER CARBONATE	AiPing Pharmaceutical, Inc.	0cade89a-38ca-4072-97a0-be09c6e058f4	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215998 application number: ANDA215998 ndc (product): 11788-116

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	0cade89a-38ca-4072-97a0-be09c6e058f4	2
749206	sevelamer carbonate 800 MG Oral Tablet	PSN	b72baeeb-b6f5-4fa1-bee8-9eb4bb74dc82	2
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	0cade89a-38ca-4072-97a0-be09c6e058f4	2
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	b72baeeb-b6f5-4fa1-bee8-9eb4bb74dc82	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
11788-116-07	11788011607	270 TABLET in 1 BOTTLE (11788-116-07)	270 tablet	2025-12-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SEVELAMER CARBONATE	PD-Rx Pharmaceuticals, Inc.	2026-04-17	HUMAN PRESCRIPTION DRUG LABEL	2
SEVELAMER CARBONATE	AiPing Pharmaceutical, Inc. \| Shandong Xinhua Pharmaceutical Co., Ltd.	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	2