Home NDC 51660-995 Colesevelam hydrochloride
Product NDC 51660-995
11-digit product format 516600995
Labeler code 51660
Product ID 51660-995_036fdbc5-98b7-41bb-9f84-871d980167ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name colesevelam hydrochloride
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Ohm Laboratories, Inc.
Application NDA022362
Marketing category NDA
Marketing start 2018-07-17
Marketing end 2023-11-30
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022362-001 WELCHOL COLESEVELAM HYDROCHLORIDE 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 N022362-002 WELCHOL COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022362-002 AB
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 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022362-001 WELCHOL 1.875GM/PACKET FOR SUSPENSION / ORAL RLD 2009-10-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022362-001 WELCHOL 1.875GM/PACKET FOR SUSPENSION / ORAL RLD 2009-10-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022362-001 WELCHOL 1.875GM/PACKET FOR SUSPENSION / ORAL RLD 2009-10-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022362-001 7229613 2022-04-17 U-493 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022362-001 7229613*PED 2022-10-17 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022362-002 7229613 2022-04-17 U-493 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022362-002 7229613*PED 2022-10-17 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022362-001 7229613 2022-04-17 U-493 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022362-001 7229613*PED 2022-10-17 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022362-002 7229613 2022-04-17 U-493 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022362-002 7229613*PED 2022-10-17 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022362-001 7229613 2022-04-17 U-493 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022362-001 7229613*PED 2022-10-17 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022362-002 7229613 2022-04-17 U-493 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022362-002 7229613*PED 2022-10-17 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022362-001 7229613 2022-04-17 U-493 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022362-001 7229613*PED 2022-10-17 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022362-002 7229613 2022-04-17 U-493 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022362-002 7229613*PED 2022-10-17 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022362-001 7229613 2022-04-17 U-493 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022362-001 7229613*PED 2022-10-17 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022362-002 7229613 2022-04-17 U-493 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022362-002 7229613*PED 2022-10-17 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022362-001 7229613 2022-04-17 U-493 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022362-001 7229613*PED 2022-10-17 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022362-002 7229613 2022-04-17 U-493 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022362-002 7229613*PED 2022-10-17 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022362-001 7229613 2022-04-17 U-493 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022362-001 7229613*PED 2022-10-17 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022362-002 7229613 2022-04-17 U-493 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022362-002 7229613*PED 2022-10-17 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022362-001 7229613 2022-04-17 U-493 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022362-001 7229613*PED 2022-10-17 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022362-002 7229613 2022-04-17 U-493 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022362-002 7229613*PED 2022-10-17 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022362-001 7229613 2022-04-17 U-493 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022362-001 7229613*PED 2022-10-17 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022362-002 7229613 2022-04-17 U-493 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022362-002 7229613*PED 2022-10-17 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022362-001 7229613 2022-04-17 U-493 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022362-001 7229613*PED 2022-10-17 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022362-002 7229613 2022-04-17 U-493 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022362-002 7229613*PED 2022-10-17 Pediatric extension c0c555d07b60…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 observed states.
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51660-995-30 51660099530 30 PACKET in 1 CARTON (51660-995-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET 30 packet 2018-07-17 2023-11-30 No No Current