Colesevelam HCL

Product NDC: 63629-8767
11-digit product format: 636298767
Labeler code: 63629
Product ID: 63629-8767_7802c4a7-198d-44ec-9bed-f480362c5d07
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colesevelam HCL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209038
Marketing category: ANDA
Marketing start: 2018-10-06
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
A209038-001	COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB		2018-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209038-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209038-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209038-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209038-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209038-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209038-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209038-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209038-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209038-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209038-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209038-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209038-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209038-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209038-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209038-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209038-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209038-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209038-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209038-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209038-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209038-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209038-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209038-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209038-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209038-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209038-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209038-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209038-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209038-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209038-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209038-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209038-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209038-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209038-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209038-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209038-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209038-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209038-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209038-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209038-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209038-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Colesevelam HCL
Listing expiration: 2027-12-31

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
5d1b8dfd-cfe7-4c86-9d7b-a709b593acf7	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
63629-8767-1	Colesevelam HCL	180 in 1 BOTTLE	TABLET, FILM COATED	180		105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8767-1	EA - Each	63629-8767	890ac271-62d2-4fd7-9ccc-4996ec6a955d	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8767	COLESEVELAM HCL TABLET, FILM COATED [BRYANT RANCH PREPACK]	105	Current NDC, Legacy NDC, 1 package rows	20240504_5d1b8dfd-cfe7-4c86-9d7b-a709b593acf7.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colesevelam HCL	COLESEVELAM HCL	Bryant Ranch Prepack	5d1b8dfd-cfe7-4c86-9d7b-a709b593acf7	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038 ndc (product): 63629-8767
Colesevelam HCL	COLESEVELAM HCL	Ascend Laboratories, LLC	4ffd02a3-86b8-4af7-b539-aa32e38c6b12	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038
Colesevelam HCL	COLESEVELAM HCL	A-S Medication Solutions	5eb26657-09cf-4229-a567-1395b58bba6b	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038
Colesevelam HCL	COLESEVELAM HCL	A-S Medication Solutions	62ea3a03-5cd0-4adc-8464-c7d8b00cd0de	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038
Colesevelam HCL	COLESEVELAM HCL	Bryant Ranch Prepack	22cf31e6-59fa-40db-a181-2a12afc3af43	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038
Colesevelam HCL	COLESEVELAM HCL	PD-Rx Pharmaceuticals, Inc.	66a0f44e-3e68-4a67-a3d0-21a0bf99c9cb	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038
Colesevelam HCL	COLESEVELAM HCL	Bryant Ranch Prepack	ffac398c-3eb7-482a-80ce-0ad2cbd2bdca	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038

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	5d1b8dfd-cfe7-4c86-9d7b-a709b593acf7	105
866910	colesevelam hydrochloride 625 MG Oral Tablet	SCD	5d1b8dfd-cfe7-4c86-9d7b-a709b593acf7	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8767-1	63629876701	180 TABLET, FILM COATED in 1 BOTTLE (63629-8767-1)	2018-10-06	0000-00-00	No	No	Current