Cholestyramine

Product NDC: 50090-3415
Requested package NDC: 50090-3415-0
11-digit product format: 500903415
Labeler code: 50090
Product ID: 50090-3415_8294e797-9a67-44a8-a0e2-11fdceb677a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cholestyramine
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077204
Marketing category: ANDA
Marketing start: 2005-09-15
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-3415	50090-3415-0	I	Inactivated by FDA		2026-08-17

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 · 15 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…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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.

Application-product, TE code table
Application-product	TE code
A077204-001	AB
A077204-002	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 3 · 84 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
2026-08-18 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077204-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077204-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077204-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077204-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077204-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077204-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077204-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077204-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077204-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077204-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077204-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077204-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077204-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077204-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077204-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077204-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077204-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077204-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077204-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077204-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077204-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077204-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077204-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077204-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077204-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077204-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077204-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077204-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077204-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077204-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077204-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077204-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077204-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077204-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077204-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077204-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077204-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077204-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077204-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077204-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bafdcfac-da3a-43c4-81f4-296b60084636	Product name	6	20250623

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3415-0	2023-01-30	C162847	48780-1	f386c649-ccfd-0266-e053-dadaa90a7c1a	Cholestyramine for Oral Suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3415-0	Cholestyramine	60 in 1 CARTON	POWDER, FOR SUSPENSION	60		1
50090-3415-0	Cholestyramine	9 g in 1 PACKET	POWDER, FOR SUSPENSION	9		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3415	CHOLESTYRAMINE POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 2 package rows	20210303_543797f2-6721-436d-8de3-60822ff825a4.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cholestyramine	CHOLESTYRAMINE	Bryant Ranch Prepack	cc447b99-e654-42dd-8cf1-f9e7952a25cd	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077204 application number: ANDA077204
Cholestyramine	CHOLESTYRAMINE	Bryant Ranch Prepack	2998a314-deb2-4a02-afab-7e8c868888e2	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077204 application number: ANDA077204
Cholestyramine	CHOLESTYRAMINE	Par Health USA, LLC	b0c65058-22c3-4f57-9b61-9bc6fcd6e240	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077204 application number: ANDA077204
QUESTRAN	CHOLESTYRAMINE	Endo USA, Inc.	362ddd91-a63f-4ec6-841a-75785dd208c8	2024-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077204 application number: ANDA077204

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
848943	cholestyramine resin 4 GM Powder for Oral Suspension	PSN	543797f2-6721-436d-8de3-60822ff825a4	1
848943	cholestyramine resin 4000 MG Powder for Oral Suspension	SCD	543797f2-6721-436d-8de3-60822ff825a4	1
848943	cholestyramine resin 4 GM per 9 GM Powder for Oral Suspension	SY	543797f2-6721-436d-8de3-60822ff825a4	1
848943	cholestyramine resin 4 GM Powder for Oral Suspension	SY	543797f2-6721-436d-8de3-60822ff825a4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3415-0	50090341500	60 PACKET in 1 CARTON (50090-3415-0) > 9 g in 1 PACKET	60 packet	2018-03-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cholestyramine for Oral Suspension	A-S Medication Solutions	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	1