Home NDC 42571-508 Cholestyramine
Product NDC 42571-508
11-digit product format 425710508
Labeler code 42571
Product ID 42571-508_4c544fbf-3a7e-d5fa-e063-6394a90a176f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cholestyramine
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Micro Labs Limited
Application ANDA219318
Marketing category ANDA
Marketing start 2026-04-01
Substance CHOLESTYRAMINE
Active strength 4 g/9g
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 42 .
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 A219318-001 CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2026-03-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219318-001 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 2026-08-18 06:07:40 2026-07 A219318-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2026-03-05 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219318-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2026-03-05 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A219318-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219318-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Cholestyramine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHOLESTYRAMINE 4 g/9g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4B33BGI082 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 848943 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 42571-508-04 Cholestyramine 9 g in 1 POUCH POWDER, FOR SUSPENSION 9 1 42571-508-29 Cholestyramine 60 in 1 CARTON POWDER, FOR SUSPENSION 60 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42571-508-04 42571050804 9 g in 1 POUCH 9 g Historical 42571-508-29 42571050829 60 POUCH in 1 CARTON (42571-508-29) / 9 g in 1 POUCH (42571-508-04) 60 pouch 2026-04-01 No No Current