Home DailyMed 49283e21-0565-44ff-aa0b-4e17faa889e6 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:39:57 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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WELCHOL COLESEVELAM HYDROCHLORIDE 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 N022362-002 WELCHOL COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION / ORAL AB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 · 88 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 2026-10-15 13:18:30 2026-09 N022362-001 WELCHOL 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2009-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022362-002 WELCHOL 3.75GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-10-02 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.