Home NDC 72162-1847 Colesevelam hydrochloride
Product NDC 72162-1847
11-digit product format 721621847
Labeler code 72162
Product ID 72162-1847_09190787-5459-41b0-8653-ac4737a1f3c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colesevelam hydrochloride
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Bryant Ranch Prepack
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 2027-12-31
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 2027-12-31 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 72162-1847-2 Colesevelam hydrochloride 30 in 1 PACKET POWDER, FOR SUSPENSION 30 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-1847 COLESEVELAM HYDROCHLORIDE POWDER, FOR SUSPENSION [BRYANT RANCH PREPACK] 102 Current NDC, 1 package rows 20240710_dbed6967-b261-44a1-bee4-638810e2efe9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72162-1847-2 72162184702 30 POWDER, FOR SUSPENSION in 1 PACKET (72162-1847-2) 2024-03-12 No No Current