Colesevelam hydrochloride

Product NDC: 50090-7604
11-digit product format: 500907604
Labeler code: 50090
Product ID: 50090-7604_1f95ff46-b4bf-42d3-b39b-b7221c7e07da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colesevelam hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA209946
Marketing category: ANDA
Marketing start: 2020-10-19
Substance: COLESEVELAM HYDROCHLORIDE
Active strength: 625 mg/1
Pharmacologic classes: Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209946-001	COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB		2020-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209946-001	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.

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	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209946-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2020-07-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209946-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209946-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209946-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209946-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209946-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209946-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209946-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209946-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209946-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209946-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209946-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209946-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209946-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209946-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209946-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209946-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209946-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209946-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209946-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209946-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209946-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209946-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209946-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209946-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209946-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209946-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209946-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209946-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209946-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209946-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209946-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209946-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209946-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209946-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209946-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209946-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209946-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209946-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Colesevelam hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
COLESEVELAM HYDROCHLORIDE	625 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P4SG24WI5Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866910	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
b48a7426-b513-4790-99a4-4f07d83318d7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
78368210-61ea-2003-e774-9745708f5823	Product name	9	20220328

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-7604-0	Colesevelam hydrochloride	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7604-0	EA - Each	50090-7604	0df41f4c-3d77-4785-9909-6231c781fdfe	1	2025-08-11

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
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	Golden State Medical Supply, Inc.	c7058806-ad4f-6d5f-e053-2a95a90a35e8	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209946 application number: ANDA209946
Colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	A-S Medication Solutions	0f235408-e28d-4cce-b7f1-66bbe0e4534c	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209946 application number: ANDA209946
Colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	A-S Medication Solutions	b48a7426-b513-4790-99a4-4f07d83318d7	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209946 application number: ANDA209946 ndc (product): 50090-7604
Colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	Cranbury Pharmaceuticals, LLC	5e50cc0c-03bc-444b-9d15-ea112bc0f91c	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209946 application number: ANDA209946

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P4SG24WI5Q	COLESEVELAM HYDROCHLORIDE	182815-44-7	COLESEVELAM HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866910	colesevelam HCl 625 MG Oral Tablet	PSN	b48a7426-b513-4790-99a4-4f07d83318d7	1
866910	colesevelam hydrochloride 625 MG Oral Tablet	SCD	b48a7426-b513-4790-99a4-4f07d83318d7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7604-0	50090760400	90 TABLET in 1 BOTTLE (50090-7604-0)	90 tablet	2025-07-16	No	No	Current