Cholestyramine Light

Product NDC: 51224-009
11-digit product format: 512240009
Labeler code: 51224
Product ID: 51224-009_fb8b0e9c-1750-4016-95c7-d7a49e09d463
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cholestyramine
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: TAGI Pharma, Inc.
Application: ANDA209599
Marketing category: ANDA
Marketing start: 2020-11-12
Marketing end: 2027-01-31
Substance: CHOLESTYRAMINE
Active strength: 4 g/4.8g
Pharmacologic classes: Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag: No
Current FDA listing: Yes

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	51224-009	51224-009-20	D	Discontinued by firm		2026-08-11

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
A209599-001	CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB		2020-11-12
A209599-002	CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		2020-11-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209599-001	AB
A209599-002	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 · 72 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
2026-02-19 14:30 UTC	2026-02	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209599-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2020-11-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209599-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2020-11-12	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 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	A209599-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209599-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209599-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209599-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209599-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209599-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209599-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209599-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209599-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209599-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209599-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209599-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209599-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209599-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209599-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209599-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209599-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209599-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209599-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209599-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209599-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209599-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209599-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209599-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209599-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209599-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209599-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209599-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209599-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209599-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209599-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209599-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209599-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209599-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209599-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209599-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209599-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209599-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209599-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209599-002	AB	1	`87673890dc5c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cholestyramine Light

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHOLESTYRAMINE	4 g/4.8g

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
1801279	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
eb85a2c8-cdc3-48bb-844d-e220ae3701a0	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51224-009-10	Cholestyramine Light	201.6 g in 1 CAN	POWDER, FOR SUSPENSION	201.6	4
51224-009-20	Cholestyramine Light	60 in 1 CARTON	POWDER, FOR SUSPENSION	60	4
51224-009-20	Cholestyramine Light	4.8 g in 1 POUCH	POWDER, FOR SUSPENSION	4.8	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51224-009-10	GM - Gram	51224-009	9deb3385-4a6f-40d6-82b9-79c6082f9d64	1	2021-11-09
51224-009-20	EA - Each	51224-009	560ca710-c9fd-4c58-84c0-dde26b5da937	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51224-009	CHOLESTYRAMINE LIGHT (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [TAGI PHARMA, INC.]	4	Current NDC, Legacy NDC, 3 package rows	20250424_eb85a2c8-cdc3-48bb-844d-e220ae3701a0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cholestyramine Light	CHOLESTYRAMINE	TAGI Pharma, Inc.	eb85a2c8-cdc3-48bb-844d-e220ae3701a0	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209599 application number: ANDA209599 ndc (product): 51224-009
Cholestyramine	CHOLESTYRAMINE	Precision Dose, Inc.	129fa522-b66b-4bb1-9ac6-74f98d93a86f	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209599 application number: ANDA209599

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
1801279	cholestyramine Sugar-Free 4 GM Powder for Oral Suspension	PSN	eb85a2c8-cdc3-48bb-844d-e220ae3701a0	4
1801279	Sugar-Free cholestyramine resin 4000 MG Powder for Oral Suspension	SCD	eb85a2c8-cdc3-48bb-844d-e220ae3701a0	4
1801279	cholestyramine Sugar-Free 4 GM Powder for Oral Suspension	SY	eb85a2c8-cdc3-48bb-844d-e220ae3701a0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51224-009-10	51224000910	201.6 g in 1 CAN (51224-009-10)	201.6 g	2020-11-12	2027-01-31	No	No	Current
51224-009-20	51224000920	60 POUCH in 1 CARTON (51224-009-20) > 4.8 g in 1 POUCH	60 pouch	2020-11-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cholestyramine for Oral Suspension USP, Light	TAGI Pharma, Inc. \| Laboratorios Rubió, S.A.	2025-04-17	HUMAN PRESCRIPTION DRUG LABEL	4