Welchol

Product NDC
65597-701
11-digit product format
655970701
Labeler code
65597
Product ID
65597-701_3e806127-4a87-41cc-9b17-a77e20bb2452
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colesevelam hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Daiichi Sankyo Inc.
Application
NDA021176
Marketing category
NDA
Marketing start
2000-09-01
Marketing end
2025-09-30
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
0000-00-00
Current FDA listing
Historical FDA.report record

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 productproduct65597-701DDiscontinued by firm2026-08-17
excluded packagepackage65597-70165597-701-18DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct65597-701DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65597-70165597-701-18DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65597-701-18EA - Each65597-70194ce0a17-5983-4799-92f2-1dec7e91416d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLESEVELAM HYDROCHLORIDEACTIVE INGREDIENTP4SG24WI5QWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [DAIICHI SANKYO, INC.]17
COLESEVELAMACTIVE MOIETY1XU104G55NWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [DAIICHI SANKYO, INC.]17
COLESEVELAM HYDROCHLORIDEACTIVE INGREDIENTP4SG24WI5QWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
COLESEVELAM HYDROCHLORIDEACTIVE INGREDIENTP4SG24WI5QWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
COLESEVELAMACTIVE MOIETY1XU104G55NWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
COLESEVELAMACTIVE MOIETY1XU104G55NWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM TRISILICATEINACTIVE INGREDIENTC2E1CI501TWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOL ALGINATEINACTIVE INGREDIENT26CD3J2R0CWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
COLESEVELAM HYDROCHLORIDEACTIVE INGREDIENTP4SG24WI5QWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
COLESEVELAMACTIVE MOIETY1XU104G55NWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESINACTIVE INGREDIENTU72Q2I8C85WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
MAGNESIUM TRISILICATEINACTIVE INGREDIENTC2E1CI501TWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOL ALGINATEINACTIVE INGREDIENT26CD3J2R0CWELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65597-701WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION WELCHOL (COLESEVELAM HYDROCHLORIDE) BAR, CHEWABLE [DAIICHI SANKYO INC.]35Legacy NDC20220617_4a06d3b2-7229-4398-baba-5d0a72f63821.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
866910colesevelam HCl 625 MG Oral TabletPSN725dd631-75be-4e9b-82d8-d2c8dfcb917b3
866912Welchol 625 MG Oral TabletPSN725dd631-75be-4e9b-82d8-d2c8dfcb917b3
866912colesevelam hydrochloride 625 MG Oral Tablet [Welchol]SBD725dd631-75be-4e9b-82d8-d2c8dfcb917b3
866910colesevelam hydrochloride 625 MG Oral TabletSCD725dd631-75be-4e9b-82d8-d2c8dfcb917b3
866912Welchol 625 MG Oral TabletSY725dd631-75be-4e9b-82d8-d2c8dfcb917b3
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionPSNb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866910colesevelam HCl 625 MG Oral TabletPSNb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866907Welchol 3.75 GM Powder for Oral SuspensionPSNb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866912Welchol 625 MG Oral TabletPSNb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866907colesevelam hydrochloride 3750 MG Powder for Oral Suspension [Welchol]SBDb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866912colesevelam hydrochloride 625 MG Oral Tablet [Welchol]SBDb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866905colesevelam hydrochloride 3750 MG Powder for Oral SuspensionSCDb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866910colesevelam hydrochloride 625 MG Oral TabletSCDb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionSYb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866907Welchol 3.75 GM Powder for Oral SuspensionSYb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866907Welchol 3750 MG Powder for Oral SuspensionSYb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866912Welchol 625 MG Oral TabletSYb9df447c-b65b-45b9-873a-07a2ab6e2d1f2
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionPSNfc274f83-4cd6-47bd-b43e-53a0bf345f111
866910colesevelam HCl 625 MG Oral TabletPSNfc274f83-4cd6-47bd-b43e-53a0bf345f111
866907Welchol 3.75 GM Powder for Oral SuspensionPSNfc274f83-4cd6-47bd-b43e-53a0bf345f111
866912Welchol 625 MG Oral TabletPSNfc274f83-4cd6-47bd-b43e-53a0bf345f111
866907colesevelam hydrochloride 3750 MG Powder for Oral Suspension [Welchol]SBDfc274f83-4cd6-47bd-b43e-53a0bf345f111
866912colesevelam hydrochloride 625 MG Oral Tablet [Welchol]SBDfc274f83-4cd6-47bd-b43e-53a0bf345f111
866905colesevelam hydrochloride 3750 MG Powder for Oral SuspensionSCDfc274f83-4cd6-47bd-b43e-53a0bf345f111
866910colesevelam hydrochloride 625 MG Oral TabletSCDfc274f83-4cd6-47bd-b43e-53a0bf345f111
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionSYfc274f83-4cd6-47bd-b43e-53a0bf345f111
866907Welchol 3.75 GM Powder for Oral SuspensionSYfc274f83-4cd6-47bd-b43e-53a0bf345f111
866907Welchol 3750 MG Powder for Oral SuspensionSYfc274f83-4cd6-47bd-b43e-53a0bf345f111
866912Welchol 625 MG Oral TabletSYfc274f83-4cd6-47bd-b43e-53a0bf345f111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65597-701-1865597070118180 TABLET, FILM COATED in 1 BOTTLE (65597-701-18) 2000-09-010000-00-00NoNoCurrent