Home NDC 49884-465 Cholestyramine
Product NDC 49884-465
11-digit product format 498840465
Labeler code 49884
Product ID 49884-465_87b221bb-fa87-408b-90e6-2e9de29c92cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cholestyramine
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Par Health USA, LLC
Application ANDA077204
Marketing category ANDA
Marketing start 2005-09-15
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A077204-001 CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 A077204-002 CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 84 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 2026-08-18 06:07:40 2026-07 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077204-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2005-08-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077204-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2005-08-26 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 848943 Internal RxNorm lookup 1801279 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 49884-465-51 Cholestyramine 378 g in 1 BOTTLE POWDER, FOR SUSPENSION 378 17 49884-465-64 Cholestyramine 9 g in 1 PACKET POWDER, FOR SUSPENSION 9 17 49884-465-65 Cholestyramine 60 in 1 CARTON POWDER, FOR SUSPENSION 60 17 49884-465-66 Cholestyramine 378 g in 1 CAN POWDER, FOR SUSPENSION 378 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHOLESTYRAMINE ACTIVE INGREDIENT 4B33BGI082 CHOLESTYRAMINE POWDER, FOR SUSPENSION [PAR PHARMACEUTICAL, INC.] 7 CHOLESTYRAMINE ACTIVE MOIETY 4B33BGI082 CHOLESTYRAMINE POWDER, FOR SUSPENSION [PAR PHARMACEUTICAL, INC.] 7 ACACIA INACTIVE INGREDIENT 5C5403N26O CHOLESTYRAMINE POWDER, FOR SUSPENSION [PAR PHARMACEUTICAL, INC.] 7 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CHOLESTYRAMINE POWDER, FOR SUSPENSION [PAR PHARMACEUTICAL, INC.] 7 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 CHOLESTYRAMINE POWDER, FOR SUSPENSION [PAR PHARMACEUTICAL, INC.] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CHOLESTYRAMINE POWDER, FOR SUSPENSION [PAR PHARMACEUTICAL, INC.] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CHOLESTYRAMINE POWDER, FOR SUSPENSION [PAR PHARMACEUTICAL, INC.] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CHOLESTYRAMINE POWDER, FOR SUSPENSION [PAR PHARMACEUTICAL, INC.] 7 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D CHOLESTYRAMINE POWDER, FOR SUSPENSION [PAR PHARMACEUTICAL, INC.] 7 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CHOLESTYRAMINE POWDER, FOR SUSPENSION [PAR PHARMACEUTICAL, INC.] 7 PROPYLENE GLYCOL ALGINATE INACTIVE INGREDIENT 26CD3J2R0C CHOLESTYRAMINE POWDER, FOR SUSPENSION [PAR PHARMACEUTICAL, INC.] 7 SUCROSE INACTIVE INGREDIENT C151H8M554 CHOLESTYRAMINE POWDER, FOR SUSPENSION [PAR PHARMACEUTICAL, INC.] 7 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CHOLESTYRAMINE POWDER, FOR SUSPENSION [PAR PHARMACEUTICAL, INC.] 7 CHOLESTYRAMINE ACTIVE INGREDIENT 4B33BGI082 CHOLESTYRAMINE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 CHOLESTYRAMINE ACTIVE MOIETY 4B33BGI082 CHOLESTYRAMINE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 ACACIA INACTIVE INGREDIENT 5C5403N26O CHOLESTYRAMINE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 CHOLESTYRAMINE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 CITRIC ACID ANHYDROUS INACTIVE INGREDIENT XF417D3PSL CHOLESTYRAMINE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CHOLESTYRAMINE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CHOLESTYRAMINE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CHOLESTYRAMINE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D CHOLESTYRAMINE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CHOLESTYRAMINE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL ALGINATE INACTIVE INGREDIENT 26CD3J2R0C CHOLESTYRAMINE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 CHOLESTYRAMINE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CHOLESTYRAMINE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-465 CHOLESTYRAMINE POWDER, FOR SUSPENSION [ENDO USA, INC.] 16 Current NDC, Legacy NDC, 4 package rows 20241212_b0c65058-22c3-4f57-9b61-9bc6fcd6e240.zip
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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49884-465-51 49884046551 378 g in 1 BOTTLE (49884-465-51) 378 g 2026-04-24 No No Current 49884-465-64 49884046564 9 g in 1 PACKET 9 g Historical 49884-465-65 49884046565 60 PACKET in 1 CARTON (49884-465-65) / 9 g in 1 PACKET (49884-465-64) 60 packet 2005-09-15 0000-00-00 No No Current 49884-465-66 49884046566 378 g in 1 CAN (49884-465-66) 378 g 2005-09-15 0000-00-00 No No Current