Home NDC 67877-523 Colesevelam hydrochloride
Product NDC 67877-523
11-digit product format 678770523
Labeler code 67877
Product ID 67877-523_28be90eb-5090-4aba-ae6e-8a4332ccfbe2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colesevelam hydrochloride
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA210316
Marketing category ANDA
Marketing start 2019-05-09
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 A210316-001 COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION / ORAL AB 2019-05-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210316-001 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.
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 A210316-001 COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION / ORAL AB 2019-05-06 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A210316-001 AB 1 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 · 3 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 67877-523-30 Colesevelam hydrochloride 30 in 1 PACKET POWDER, FOR SUSPENSION 30 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-523 COLESEVELAM HYDROCHLORIDE POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] 14 Current NDC, Legacy NDC, 1 package rows 20230217_dfce5bc5-58fc-4fe5-b5c0-7a8026ee2b96.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67877-523-30 67877052330 30 POWDER, FOR SUSPENSION in 1 PACKET (67877-523-30) 2019-05-09 0000-00-00 No No Current