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…

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

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
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

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