SEVELAMER CARBONATE

Product NDC: 72789-562
Requested package NDC: 72789-562-94
11-digit product format: 727890562
Labeler code: 72789
Product ID: 72789-562_4faaca2e-237f-58ee-e063-6394a90acd4b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SEVELAMER CARBONATE
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, 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: 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 · 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
2026-02-19 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
2026-02-19 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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 72789-562-94 ndc (product): 72789-562 ndc11 (package): 72789056294
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

Additional Listing Data#

Finished product: Yes
Brand name base: SEVELAMER CARBONATE
Listing expiration: 2027-12-31

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
b72baeeb-b6f5-4fa1-bee8-9eb4bb74dc82	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
72789-562-94	SEVELAMER CARBONATE	270 in 1 BOTTLE, PLASTIC	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
72789-562-94	EA - Each	72789-562	51fbfc9a-d73c-468a-9534-f0a600b87577	1	2026-05-22

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	b72baeeb-b6f5-4fa1-bee8-9eb4bb74dc82	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
72789-562-94	72789056294	270 TABLET in 1 BOTTLE, PLASTIC (72789-562-94)	270 tablet	2026-04-16	No	No	Current