COLESEVELAM HYDROCHLORIDE

Product NDC: 69452-582
11-digit product format: 694520582
Labeler code: 69452
Product ID: 69452-582_5ca9a9b7-5efc-09bf-e063-6294a90a681d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: colesevelam hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA208670
Marketing category: ANDA
Marketing start: 2026-09-30
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: 2027-12-31
Current FDA listing: Yes

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
A208670-001	COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB		2019-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208670-001	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 · 41 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	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208670-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-09-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A208670-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208670-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208670-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208670-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208670-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208670-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208670-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208670-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208670-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208670-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208670-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208670-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208670-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208670-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208670-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208670-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208670-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208670-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208670-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208670-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208670-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208670-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208670-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208670-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208670-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208670-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208670-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208670-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208670-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208670-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208670-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208670-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208670-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208670-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208670-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208670-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208670-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208670-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208670-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208670-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: COLESEVELAM HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

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

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
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	Bionpharma Inc.	4aa52225-9214-59dc-e063-6294a90a5f75	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208670 application number: ANDA208670
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	Bionpharma Inc.	a2c5e881-2901-4f90-95cc-74930569e51e	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208670 application number: ANDA208670

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

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
141625	colesevelam hydrochloride	colesevelam hydrochloride	PIN Active

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69452-582-25	69452058225	180 TABLET, FILM COATED in 1 BOTTLE (69452-582-25)	2026-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COLESEVELAM HYDROCHLORIDE	Bionpharma Inc. \| OrBion Pharmaceuticals Private Limited	2026-09-29	HUMAN PRESCRIPTION DRUG LABEL	1