Colesevelam Hydrochloride

Product NDC: 68462-620
11-digit product format: 684620620
Labeler code: 68462
Product ID: 68462-620_82044bf3-865e-4816-a6a2-f648d980fff2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colesevelam Hydrochloride
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc.,USA
Application: ANDA202190
Marketing category: ANDA
Marketing start: 2018-07-16
Substance: COLESEVELAM HYDROCHLORIDE
Active strength: 3.75 g/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 42.

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
A202190-001	COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL			2018-07-16
A202190-002	COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB		2018-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202190-002	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 3 · 84 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	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202190-001	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION / ORAL		2018-07-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202190-002	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	2018-07-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 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	A202190-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202190-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202190-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202190-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202190-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202190-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202190-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202190-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202190-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202190-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202190-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202190-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202190-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202190-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202190-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202190-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202190-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202190-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202190-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202190-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202190-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202190-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202190-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202190-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202190-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202190-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202190-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202190-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202190-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202190-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202190-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202190-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202190-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202190-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202190-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202190-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202190-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202190-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202190-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202190-002	AB	1	`3bdfa0b2c4d7…`

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	3.75 g/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
866905	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
2e736dd4-bb64-4f93-9821-7c24ea7d38ec	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-620-30	Colesevelam Hydrochloride	1 in 1 PACKET	POWDER, FOR SUSPENSION	1		10
68462-620-30	Colesevelam Hydrochloride	30 in 1 BOX	POWDER, FOR SUSPENSION	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-620-30	EA - Each	68462-620	e273047a-7e5b-424f-a1be-7a7c510d113f	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-620	COLESEVELAM HYDROCHLORIDE POWDER, FOR SUSPENSION [GLENMARK PHARMACEUTICALS INC.,USA]	9	Current NDC, Legacy NDC, 2 package rows	20230810_2e736dd4-bb64-4f93-9821-7c24ea7d38ec.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 · 1 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	2e736dd4-bb64-4f93-9821-7c24ea7d38ec	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202190 application number: ANDA202190 ndc (product): 68462-620

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
866905	colesevelam HCl 3.75 GM Powder for Oral Suspension	PSN	2e736dd4-bb64-4f93-9821-7c24ea7d38ec	10
866905	colesevelam hydrochloride 3750 MG Powder for Oral Suspension	SCD	2e736dd4-bb64-4f93-9821-7c24ea7d38ec	10
866905	colesevelam HCl 3.75 GM Powder for Oral Suspension	SY	2e736dd4-bb64-4f93-9821-7c24ea7d38ec	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-620-30	68462062030	30 PACKET in 1 BOX (68462-620-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET	30 packet	2018-07-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colesevelam Hydrochloride	Glenmark Pharmaceuticals Inc.,USA \| Glenmark Pharmaceuticals Limited	2026-01-28	HUMAN PRESCRIPTION DRUG LABEL	10