Home NDC 68382-528 CHOLESTYRAMINE
Product NDC 68382-528
11-digit product format 683820528
Labeler code 68382
Product ID 68382-528_05ac7932-41c3-4434-8655-d47bfa6db8b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CHOLESTYRAMINE
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA202901
Marketing category ANDA
Marketing start 2018-08-01
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 A202901-001 CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202901-001 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.
Product history page 1 of 2 · 42 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 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202901-001 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2018-07-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 · 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 68382-528-42 CHOLESTYRAMINE 378 g in 1 CAN POWDER, FOR SUSPENSION 378 6 68382-528-60 CHOLESTYRAMINE 60 in 1 CARTON POWDER, FOR SUSPENSION 60 6 68382-528-60 CHOLESTYRAMINE 9 g in 1 POUCH POWDER, FOR SUSPENSION 9 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-528 CHOLESTYRAMINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS (USA) INC.] 5 Current NDC, Legacy NDC, 3 package rows 20240110_acc48703-c15b-4275-aa75-749f1c07dcbb.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 · 2 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 68382-528-42 68382052842 378 g in 1 CAN (68382-528-42) 378 g 2018-08-01 0000-00-00 No No Current 68382-528-60 68382052860 60 POUCH in 1 CARTON (68382-528-60) / 9 g in 1 POUCH 60 pouch 2018-08-01 0000-00-00 No No Current