Home NDC 63629-2164 Cholestyramine
Product NDC 63629-2164
11-digit product format 636292164
Labeler code 63629
Product ID 63629-2164_273b2c4d-bae2-4fd0-8387-25ed9de84b1a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cholestyramine
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Bryant Ranch Prepack
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 2026-12-31
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 · 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 · 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 63629-2164-1 Cholestyramine 378 g in 1 CAN POWDER, FOR SUSPENSION 378 105
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2164 CHOLESTYRAMINE POWDER, FOR SUSPENSION [BRYANT RANCH PREPACK] 105 Current NDC, Legacy NDC, 1 package rows 20231202_2998a314-deb2-4a02-afab-7e8c868888e2.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 63629-2164-1 63629216401 378 g in 1 CAN (63629-2164-1) 378 g 2005-09-15 0000-00-00 No No Current