Home NDC 0115-1864 Colesevelam hydrochloride
Product NDC 0115-1864
11-digit product format 001151864
Labeler code 0115
Product ID 0115-1864_83f79a9e-7658-4d89-a3aa-8c5ee39ac846
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colesevelam hydrochloride
Dosage form FOR SUSPENSION
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA212886
Marketing category ANDA
Marketing start 2023-01-20
Substance COLESEVELAM HYDROCHLORIDE
Active strength 3.75 g/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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212886-001 COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION / ORAL 2023-01-18
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.
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 2026-08-01 22:54:32 2026-06 A212886-001 COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION / ORAL 2023-01-18 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Colesevelam hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COLESEVELAM HYDROCHLORIDE 3.75 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P4SG24WI5Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 866905 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0115-1864-18 Colesevelam hydrochloride 30 in 1 CARTON FOR SUSPENSION 30 4 0115-1864-30 Colesevelam hydrochloride 1 in 1 PACKET FOR SUSPENSION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-1864 COLESEVELAM HYDROCHLORIDE FOR SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 4 Current NDC, 2 package rows 20230120_f33fbf30-2486-49a7-bbe8-0ddfb4b9b786.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0115-1864-18 00115186418 30 PACKET in 1 CARTON (0115-1864-18) / 1 FOR SUSPENSION in 1 PACKET (0115-1864-30) 30 packet 2023-01-20 No No Current 0115-1864-30 00115186430 1 in 1 PACKET Historical