COLESEVELAM HYDROCHLORIDE

Product NDC
0713-0936
11-digit product format
007130936
Labeler code
0713
Product ID
0713-0936_2a324e3d-e3ac-c310-e063-6394a90a0950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
COLESEVELAM HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
NDA021176
Marketing category
NDA
Marketing start
2022-08-01
Substance
COLESEVELAM HYDROCHLORIDE
Active strength
625 mg/1
Pharmacologic classes
Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0713-0936IInactivated by FDA2026-08-17
excluded packagepackage0713-09360713-0936-81IInactivated by FDA2026-08-17

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021176-001WELCHOLCOLESEVELAM HYDROCHLORIDE625MGTABLET / ORALABRLD, RS2000-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021176-001AB

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-263f01610625f2…
2019-09-15 20:21 UTC2019-09N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021176-001WELCHOL625MGTABLET / ORALABRLD, RS2000-05-26e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021176-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021176-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021176-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021176-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021176-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021176-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021176-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021176-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021176-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021176-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021176-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021176-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021176-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021176-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021176-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021176-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021176-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021176-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021176-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021176-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021176-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021176-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021176-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021176-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021176-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021176-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021176-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021176-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021176-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021176-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021176-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021176-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021176-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021176-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021176-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021176-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021176-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021176-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021176-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021176-001AB1e64feba35796…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021176-00172296132022-04-17U-8515c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021176-0017229613*PED2022-10-17Pediatric extension5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021176-00172296132022-04-17U-8515d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021176-0017229613*PED2022-10-17Pediatric extension5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021176-00172296132022-04-17U-8514b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021176-0017229613*PED2022-10-17Pediatric extension4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021176-00172296132022-04-17U-85174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021176-0017229613*PED2022-10-17Pediatric extension74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021176-00172296132022-04-17U-851bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021176-0017229613*PED2022-10-17Pediatric extensionbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021176-00172296132022-04-17U-851782e0a99824c…
2021-12-28 21:50 UTC2021-12N021176-0017229613*PED2022-10-17Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021176-00172296132022-04-17U-85187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021176-0017229613*PED2022-10-17Pediatric extension87673890dc5c…
2021-03-12 10:30 UTC2021-03N021176-00172296132022-04-17U-8515aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021176-0017229613*PED2022-10-17Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021176-00172296132022-04-17U-8518869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021176-0017229613*PED2022-10-17Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021176-00172296132022-04-17U-851c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021176-0017229613*PED2022-10-17Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021176-00172296132022-04-17U-8513f01610625f2…
2019-12-14 00:12 UTC2019-12N021176-0017229613*PED2022-10-17Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021176-00172296132022-04-17U-851b00525d2431f…
2019-09-15 20:21 UTC2019-09N021176-0017229613*PED2022-10-17Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021176-00172296132022-04-17U-851ea99ee380514…
2019-07-19 19:46 UTC2019-07N021176-0017229613*PED2022-10-17Pediatric extensionea99ee380514…
2023-01-26 05:58 UTC2023-01N021176-00172296132022-04-17U-8513bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021176-0017229613*PED2022-10-17Pediatric extension3bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021176-00172296132022-04-17U-8513a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021176-0017229613*PED2022-10-17Pediatric extension3a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021176-00172296132022-04-17U-851f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021176-0017229613*PED2022-10-17Pediatric extensionf41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021176-00172296132022-04-17U-851e64feba35796…
2022-09-29 23:25 UTC2022-09N021176-0017229613*PED2022-10-17Pediatric extensione64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021176-00172296132022-04-17U-851cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021176-0017229613*PED2022-10-17Pediatric extensioncb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
78368210-61ea-2003-e774-9745708f5823Product name920220328

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0936-81COLESEVELAM HYDROCHLORIDE180 in 1 BOTTLETABLET, FILM COATED1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0936-81EA - Each0713-09365a4f812a-5139-4380-bf1b-a09f91d2e5c212022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0936COLESEVELAM HYDROCHLORIDE TABLET, FILM COATED COLESEVELAM HYDROCHLORIDE FOR SUSPENSION [COSETTE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20241228_15ceb7db-ef59-4182-99b6-09b6c3c5430a.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEA-S Medication Solutions0127afae-8d8d-43f2-97f9-4f99f6947e812023-12-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 021176
application number: NDA021176
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEA-S Medication Solutions40d66c9d-ff51-4353-8133-ae3a8eb4f7132023-12-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 021176
application number: NDA021176

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionPSN15ceb7db-ef59-4182-99b6-09b6c3c5430a4
866910colesevelam HCl 625 MG Oral TabletPSN15ceb7db-ef59-4182-99b6-09b6c3c5430a4
866905colesevelam hydrochloride 3750 MG Powder for Oral SuspensionSCD15ceb7db-ef59-4182-99b6-09b6c3c5430a4
866910colesevelam hydrochloride 625 MG Oral TabletSCD15ceb7db-ef59-4182-99b6-09b6c3c5430a4
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionSY15ceb7db-ef59-4182-99b6-09b6c3c5430a4
866910colesevelam HCl 625 MG Oral TabletPSN0127afae-8d8d-43f2-97f9-4f99f6947e811
866910colesevelam HCl 625 MG Oral TabletPSN40d66c9d-ff51-4353-8133-ae3a8eb4f7131
866910colesevelam hydrochloride 625 MG Oral TabletSCD0127afae-8d8d-43f2-97f9-4f99f6947e811
866910colesevelam hydrochloride 625 MG Oral TabletSCD40d66c9d-ff51-4353-8133-ae3a8eb4f7131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0713-0936-8100713093681180 TABLET, FILM COATED in 1 BOTTLE (0713-0936-81) 2022-08-010000-00-00NoNoCurrent