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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215998-001SEVELAMER CARBONATESEVELAMER CARBONATE800MGTABLET / ORALAB2024-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215998-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215998-001SEVELAMER CARBONATE800MGTABLET / ORALAB2024-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215998-001SEVELAMER CARBONATE800MGTABLET / ORALAB2024-10-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A215998-001SEVELAMER CARBONATE800MGTABLET / ORALAB2024-10-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215998-001SEVELAMER CARBONATE800MGTABLET / ORALAB2024-10-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215998-001SEVELAMER CARBONATE800MGTABLET / ORALAB2024-10-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215998-001SEVELAMER CARBONATE800MGTABLET / ORALAB2024-10-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215998-001SEVELAMER CARBONATE800MGTABLET / ORALAB2024-10-242680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215998-001SEVELAMER CARBONATE800MGTABLET / ORALAB2024-10-24d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215998-001SEVELAMER CARBONATE800MGTABLET / ORALAB2024-10-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215998-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215998-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215998-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215998-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215998-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215998-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215998-001AB12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215998-001AB1d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215998-001AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SEVELAMER CARBONATESEVELAMER CARBONATEPD-Rx Pharmaceuticals, Inc.b72baeeb-b6f5-4fa1-bee8-9eb4bb74dc822026-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215998
application number: ANDA215998
ndc (package): 72789-562-94
ndc (product): 72789-562
ndc11 (package): 72789056294
SEVELAMER CARBONATESEVELAMER CARBONATEShandong Xinhua Pharmaceutical Co., Ltd.f6455fa3-ad53-f6fd-e053-2a95a90a67db2025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215998
application number: ANDA215998
SEVELAMER CARBONATESEVELAMER CARBONATEAiPing Pharmaceutical, Inc.0cade89a-38ca-4072-97a0-be09c6e058f42025-12-04Warnings, Adverse reactionsExact 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
IngredientStrength
SEVELAMER CARBONATE800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9YCX42I8IUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
749206Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b72baeeb-b6f5-4fa1-bee8-9eb4bb74dc82Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5085f16b-f856-182d-a646-425b62d3f565Product name620251118
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-562-94SEVELAMER CARBONATE270 in 1 BOTTLE, PLASTICTABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-562-94EA - Each72789-56251fbfc9a-d73c-468a-9534-f0a600b8757712026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSNb72baeeb-b6f5-4fa1-bee8-9eb4bb74dc822
749206sevelamer carbonate 800 MG Oral TabletSCDb72baeeb-b6f5-4fa1-bee8-9eb4bb74dc822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-562-9472789056294270 TABLET in 1 BOTTLE, PLASTIC (72789-562-94) 270 tablet2026-04-16NoNoCurrent