Cholestyramine

Product NDC: 0832-0536
11-digit product format: 008320536
Labeler code: 0832
Product ID: 0832-0536_c5478552-9a0f-436e-bc77-d0e8436bcfb9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cholestyramine
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Upsher-Smith Laboratories,LLC
Application: ANDA214877
Marketing category: ANDA
Marketing start: 2022-01-21
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0832-0536		D	Discontinued by firm	2026-10-02
excluded package	package	0832-0536	0832-0536-42	D	Discontinued by firm	2026-10-02
excluded package	package	0832-0536	0832-0536-60	D	Discontinued by firm	2026-10-02

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0832-0536-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0832-0536-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0832-0536-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0832-0536-60	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A214877-001	CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB		2022-01-21
A214877-002	CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		2022-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214877-001	AB
A214877-002	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 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2022-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2022-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2022-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2022-01-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2022-01-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2022-01-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2022-01-21	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214877-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214877-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214877-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214877-002	AB	1	`caaa826d4ba7…`
2022-04-04 05:41 UTC	2022-04	A214877-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214877-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214877-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214877-002	AB	1	`bb7c543d1eb4…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214877-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214877-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0832-0536	CHOLESTYRAMINE POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES,LLC]	4	Legacy NDC	20230526_c378f531-b27a-47dd-889f-0c8338c123df.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cholestyramine	CHOLESTYRAMINE	AiPing Pharmaceutical, Inc.	214ea05f-de81-4026-9df9-4ce3820668ee	2026-08-20	Adverse reactions	Exact identifier application applno (ANDA): 214877 application number: ANDA214877

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4B33BGI082	CHOLESTYRAMINE	11041-12-6	CHOLESTYRAMINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0832-0536-42	00832053642	42 POUCH in 1 CARTON (0832-0536-42) > 9 g in 1 POUCH (0832-0536-89)	42 pouch	2022-01-21	0000-00-00	No	No	Current
0832-0536-60	00832053660	60 CAN in 1 CARTON (0832-0536-60) > 378 g in 1 CAN (0832-0536-37)	60 can	2022-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cholestyramine for Oral Suspension, USP	Upsher-Smith Laboratories,LLC \| Upsher-Smith Laboratories, LLC	2023-05-25	HUMAN PRESCRIPTION DRUG LABEL	4