Welchol

Product NDC
65597-902
11-digit product format
655970902
Labeler code
65597
Product ID
65597-902_3e806127-4a87-41cc-9b17-a77e20bb2452
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colesevelam hydrochloride
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Daiichi Sankyo Inc.
Application
NDA022362
Marketing category
NDA
Marketing start
2010-01-01
Marketing end
2026-02-28
Substance
COLESEVELAM HYDROCHLORIDE
Active strength
4 g/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 productproduct65597-902DDiscontinued by firm2026-08-17
excluded packagepackage65597-90265597-902-30DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022362-001WELCHOLCOLESEVELAM HYDROCHLORIDE1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-02
N022362-002WELCHOLCOLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022362-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-02caaa826d4ba7…
2026-08-18 06:07:402026-07N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022362-001WELCHOL1.875GM/PACKETFOR SUSPENSION / ORALRLD2009-10-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022362-001WELCHOL1.875GM/PACKETFOR SUSPENSION / ORALRLD2009-10-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022362-001WELCHOL1.875GM/PACKETFOR SUSPENSION / ORALRLD2009-10-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022362-001WELCHOL1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2009-10-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022362-002WELCHOL3.75GM/PACKETFOR SUSPENSION / ORALABRLD, RS2009-10-02bb7c543d1eb4…

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 06:07:402026-07N022362-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022362-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022362-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022362-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022362-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022362-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022362-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022362-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022362-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022362-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022362-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022362-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022362-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022362-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022362-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022362-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022362-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022362-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022362-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022362-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022362-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022362-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022362-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022362-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022362-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022362-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N022362-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022362-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022362-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022362-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022362-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022362-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022362-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022362-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022362-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022362-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022362-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022362-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022362-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022362-002AB1e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022362-00172296132022-04-17U-4935c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022362-0017229613*PED2022-10-17Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022362-00272296132022-04-17U-4935c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022362-0027229613*PED2022-10-17Pediatric extension5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022362-00172296132022-04-17U-4935d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022362-0017229613*PED2022-10-17Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022362-00272296132022-04-17U-4935d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022362-0027229613*PED2022-10-17Pediatric extension5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022362-00172296132022-04-17U-4934b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022362-0017229613*PED2022-10-17Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022362-00272296132022-04-17U-4934b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022362-0027229613*PED2022-10-17Pediatric extension4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022362-00172296132022-04-17U-49374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022362-0017229613*PED2022-10-17Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022362-00272296132022-04-17U-49374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022362-0027229613*PED2022-10-17Pediatric extension74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022362-00172296132022-04-17U-493bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022362-0017229613*PED2022-10-17Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022362-00272296132022-04-17U-493bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022362-0027229613*PED2022-10-17Pediatric extensionbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022362-00172296132022-04-17U-493782e0a99824c…
2021-12-28 21:50 UTC2021-12N022362-0017229613*PED2022-10-17Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N022362-00272296132022-04-17U-493782e0a99824c…
2021-12-28 21:50 UTC2021-12N022362-0027229613*PED2022-10-17Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022362-00172296132022-04-17U-49387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022362-0017229613*PED2022-10-17Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022362-00272296132022-04-17U-49387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022362-0027229613*PED2022-10-17Pediatric extension87673890dc5c…
2021-03-12 10:30 UTC2021-03N022362-00172296132022-04-17U-4935aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022362-0017229613*PED2022-10-17Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022362-00272296132022-04-17U-4935aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022362-0027229613*PED2022-10-17Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022362-00172296132022-04-17U-4938869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022362-0017229613*PED2022-10-17Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022362-00272296132022-04-17U-4938869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022362-0027229613*PED2022-10-17Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022362-00172296132022-04-17U-493c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022362-0017229613*PED2022-10-17Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022362-00272296132022-04-17U-493c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022362-0027229613*PED2022-10-17Pediatric extensionc0c555d07b60…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022362-001M-2322024-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022362-002M-2322024-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022362-001M-2322024-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022362-002M-2322024-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022362-001M-2322024-10-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022362-002M-2322024-10-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022362-001M-2322024-10-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022362-002M-2322024-10-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022362-001M-2322024-10-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N022362-002M-2322024-10-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022362-001M-2322024-10-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022362-002M-2322024-10-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022362-001M-2322024-10-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022362-002M-2322024-10-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022362-001M-2322024-10-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022362-002M-2322024-10-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022362-001M-2322024-10-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022362-002M-2322024-10-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022362-001M-2322024-10-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022362-002M-2322024-10-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022362-001M-2322024-10-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022362-002M-2322024-10-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022362-001M-2322024-10-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022362-002M-2322024-10-204b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N022362-001M-2322024-10-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022362-002M-2322024-10-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022362-001M-2322024-10-20782e0a99824c…
2021-12-28 21:50 UTC2021-12N022362-002M-2322024-10-20782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022362-001M-2322024-10-206a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022362-002M-2322024-10-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022362-001M-2322024-10-201c564ffb4f44…
2024-02-18 07:12 UTC2024-02N022362-002M-2322024-10-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022362-001M-2322024-10-20ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N022362-002M-2322024-10-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022362-001M-2322024-10-20a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022362-002M-2322024-10-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022362-001M-2322024-10-209b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022362-002M-2322024-10-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022362-001M-2322024-10-20a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022362-002M-2322024-10-20a67488948f0b…

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
65597-902-30EA - Each65597-90249283e21-0565-44ff-aa0b-4e17faa889e612012-07-24

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 WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]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
65597-902WELCHOL (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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65597-902-306559709023030 PACKET in 1 CARTON (65597-902-30) > 1 FOR SUSPENSION in 1 PACKET30 packet2010-01-010000-00-00NoNoCurrent