Cholestyramine

Product NDC: 0185-0940
11-digit product format: 001850940
Labeler code: 0185
Product ID: 0185-0940_26b5a422-6048-4b33-be55-680187a7b0f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cholestyramine
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Eon Labs, Inc.
Application: ANDA074557
Marketing category: ANDA
Marketing start: 1996-08-15
Marketing end: 2025-09-30
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: 0000-00-00
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	0185-0940		D	Discontinued by firm	2026-08-11
excluded package	package	0185-0940	0185-0940-97	D	Discontinued by firm	2026-08-11
excluded package	package	0185-0940	0185-0940-98	D	Discontinued by firm	2026-08-11

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 · 4 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	0185-0940-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0185-0940-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0185-0940-98	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074557-001	CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15
A074557-002	CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074557-001	AB
A074557-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074557-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074557-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074557-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074557-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074557-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074557-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074557-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074557-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074557-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074557-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074557-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074557-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074557-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074557-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074557-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074557-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074557-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074557-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074557-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074557-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074557-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074557-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074557-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074557-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074557-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074557-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074557-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074557-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074557-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074557-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074557-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074557-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074557-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074557-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074557-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074557-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074557-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074557-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074557-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074557-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0185-0940-97	2020-08-13	Cholestyramine for Oral Suspension, USP
0185-0940-98	2020-08-13	Cholestyramine for Oral Suspension, USP
0185-0940-97	2020-07-22	Cholestyramine for Oral Suspension, USP
0185-0940-98	2020-07-22	Cholestyramine for Oral Suspension, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0185-0940-97	GM - Gram	0185-0940	3a5bd747-869e-40c0-be23-ed14909d39cc	1	2012-07-24
0185-0940-98	EA - Each	0185-0940	e8e4a0af-c9e4-4b6a-b2ad-a6d246938490	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHOLESTYRAMINE	ACTIVE INGREDIENT	4B33BGI082	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	5
CHOLESTYRAMINE	ACTIVE MOIETY	4B33BGI082	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	5
AMMONIUM GLYCYRRHIZATE	INACTIVE INGREDIENT	3VRD35U26C	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	5
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	5
FRUCTOSE	INACTIVE INGREDIENT	6YSS42VSEV	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	5
ORANGE	INACTIVE INGREDIENT	5EVU04N5QU	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	5
PECTIN	INACTIVE INGREDIENT	89NA02M4RX	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	5
PROPYLENE GLYCOL ALGINATE	INACTIVE INGREDIENT	26CD3J2R0C	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	5
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	5
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0185-0940	CHOLESTYRAMINE POWDER, FOR SUSPENSION [EON LABS, INC.]	11	Legacy NDC	20220512_9269d9ba-d791-4865-8a39-abd1733d79bd.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	EPIC PHARMA, LLC	d02eca8c-18d4-4b11-bb16-08748543b04d	2026-06-15	Adverse reactions	Exact identifier application applno (ANDA): 074557 application number: ANDA074557
CHOLESTYRAMINE	CHOLESTYRAMINE	EPIC PHARMA, LLC	d931e372-2477-4554-912e-9d4d7d538ce2	2025-12-17	Adverse reactions	Exact identifier application applno (ANDA): 074557 application number: ANDA074557
CHOLESTYRAMINE	CHOLESTYRAMINE	EPIC PHARMA, LLC	c65e556a-3b6a-4466-a7ce-5b24103ed8ad	2025-12-17	Adverse reactions	Exact identifier application applno (ANDA): 074557 application number: ANDA074557
CHOLESTYRAMINE	CHOLESTYRAMINE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	d82647da-465b-4e2e-8cf8-72d50f047b3e	2025-12-11	Adverse reactions	Exact identifier application applno (ANDA): 074557 application number: ANDA074557

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
0185-0940-97	00185094097	378 g in 1 CAN (0185-0940-97)	378 g	1996-08-15	2025-09-30	No	No	Current
0185-0940-98	00185094098	60 POUCH in 1 CARTON (0185-0940-98) > 9 g in 1 POUCH	60 pouch	1996-08-15	2025-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cholestyramine for Oral Suspension, USP	Eon Labs, Inc.	2020-08-11	HUMAN PRESCRIPTION DRUG LABEL	11