colesevelam hydrochloride

Product NDC: 60687-621
Requested package NDC: 60687-621-25
11-digit product format: 606870621
Labeler code: 60687
Product ID: 60687-621_cf2d97e0-30c7-2ad8-e053-2995a90aa8a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: colesevelam hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA203480
Marketing category: ANDA
Marketing start: 2021-11-01
Marketing end: 0000-00-00
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: 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	60687-621	60687-621-25	D	Discontinued by firm		2026-10-05

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 · 12 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…`

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

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
A203480-001	COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB		2018-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203480-001	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.

Product history page 1 of 2 · 43 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	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203480-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203480-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203480-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203480-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203480-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203480-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203480-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203480-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203480-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203480-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203480-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203480-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203480-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203480-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203480-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203480-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203480-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203480-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203480-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203480-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203480-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203480-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203480-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203480-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203480-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203480-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203480-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203480-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203480-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203480-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203480-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203480-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203480-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203480-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203480-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203480-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203480-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203480-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203480-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203480-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203480-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	845b8661-0aa9-418f-a496-df3d7a3130ff	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203480 application number: ANDA203480
colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	A-S Medication Solutions	67820d4f-0cfb-43ca-8974-08dffe474983	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203480 application number: ANDA203480
colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	A-S Medication Solutions	79af88a5-b873-499b-a9a4-fc39624820fe	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203480 application number: ANDA203480

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-621-25	60687062125	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-621-25) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-621-95)	30 blister pack	2021-11-01	0000-00-00	No	No	Current