Home NDC 0245-0036 Prevalite
Product NDC 0245-0036
11-digit product format 002450036
Labeler code 0245
Product ID 0245-0036_44feb603-0970-9b63-e063-6294a90a7ce5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cholestyramine
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA073263
Marketing category ANDA
Marketing start 1996-02-01
Marketing end 2027-10-31
Substance CHOLESTYRAMINE
Active strength 4 g/5.5g
Pharmacologic classes Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag No
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 A073263-001 PREVALITE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 A073263-002 PREVALITE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30
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 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 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 Prevalite Active Ingredients# Ingredient, Strength table Ingredient Strength CHOLESTYRAMINE 4 g/5.5g
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 848951 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 0245-0036-23 Prevalite 231 g in 1 CAN POWDER, FOR SUSPENSION 231 9 0245-0036-42 Prevalite 42 in 1 CARTON POWDER, FOR SUSPENSION 42 9 0245-0036-60 Prevalite 60 in 1 CARTON POWDER, FOR SUSPENSION 60 9 0245-0036-89 Prevalite 5.5 g in 1 PACKET POWDER, FOR SUSPENSION 5.5 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded cholestyramine ACTIVE INGREDIENT 4B33BGI082 PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] 4 cholestyramine ACTIVE MOIETY 4B33BGI082 PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] 4 aspartame INACTIVE INGREDIENT Z0H242BBR1 PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] 4 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] 4 malic acid INACTIVE INGREDIENT 817L1N4CKP PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] 4 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] 4 propylene glycol alginate INACTIVE INGREDIENT 26CD3J2R0C PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0245-0036 PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, LLC] 7 Current NDC, Legacy NDC, 4 package rows 20200715_dd434ef8-8af3-434c-a0a0-9a0b18459ba0.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 · 1 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 0245-0036-23 00245003623 231 g in 1 CAN (0245-0036-23) 231 g 1996-02-01 2027-10-31 No No Current 0245-0036-42 00245003642 42 PACKET in 1 CARTON (0245-0036-42) / 5.5 g in 1 PACKET (0245-0036-89) 42 packet 1996-02-01 2027-10-31 No No Current 0245-0036-60 00245003660 60 PACKET in 1 CARTON (0245-0036-60) / 5.5 g in 1 PACKET (0245-0036-89) 60 packet 1996-02-01 2027-09-30 No No Current 0245-0036-89 00245003689 5.5 g in 1 PACKET 5.5 g Historical