COLESEVELAM HYDROCHLORIDE TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-26
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 21:18:21

Label at a glance#

ProductCOLESEVELAM

Active ingredientCOLESEVELAM HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colesevelam Hydrochloride Tablets, 625 mg

NDC 70771-1368-8

180 Tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
866910	colesevelam HCl 625 MG Oral Tablet	PSN	5
866910	colesevelam hydrochloride 625 MG Oral Tablet	SCD	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
COLESEVELAM Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
78368210-61ea-2003-e774-9745708f5823	Product name	9	20220328
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70771-1368-0	2024-09-04	C162847	48780-1	1030e365-0e11-111a-e063-dadaa90a10e2	COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-4	2024-09-04	C162847	48780-1	1030e365-0e11-111a-e063-dadaa90a10e2	COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-8	2024-09-04	C162847	48780-1	1030e365-0e11-111a-e063-dadaa90a10e2	COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-0	2024-01-30	C162847	48780-1	1030e365-0e11-111a-e063-dadaa90a10e2	COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-4	2024-01-30	C162847	48780-1	1030e365-0e11-111a-e063-dadaa90a10e2	COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-8	2024-01-30	C162847	48780-1	1030e365-0e11-111a-e063-dadaa90a10e2	COLESEVELAM HYDROCHLORIDE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1368-0	COLESEVELAM	1000 in 1 BOTTLE	TABLET	1000	5
70771-1368-2	COLESEVELAM	10 in 1 BLISTER PACK	TABLET	10	5
70771-1368-4	COLESEVELAM	10 in 1 CARTON	TABLET	10	5
70771-1368-8	COLESEVELAM	180 in 1 BOTTLE	TABLET	180	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1368	COLESEVELAM TABLET [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 4 package rows	20241130_090eabd5-acd3-43ed-a05b-52f1f3773a93.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

COLESEVELAM
COLESEVELAM HYDROCHLORIDE
AMMONIA
BUTYL ALCOHOL
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYPROMELLOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
MAGNESIUM STEARATE
METHACRYLIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM BICARBONATE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1368	70771-1368-8, 70771-1368-0, 70771-1368-2, 70771-1368-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
COLESEVELAM HYDROCHLORIDE	P4SG24WI5Q	ACTIB
AMMONIA	5138Q19F1X	IACT
BUTYL ALCOHOL	8PJ61P6TS3	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CROSPOVIDONE	2S7830E561	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
METHACRYLIC ACID	1CS02G8656	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
POVIDONE	FZ989GH94E	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A207765-001	COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB		2019-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207765-001	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
2026-10-15 13:18:30	2026-09	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207765-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2019-10-07	`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
2026-10-15 13:18:30	2026-09	A207765-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207765-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207765-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207765-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207765-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207765-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207765-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207765-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207765-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207765-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207765-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207765-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207765-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207765-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207765-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207765-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207765-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207765-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207765-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207765-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207765-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207765-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207765-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207765-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207765-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207765-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207765-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207765-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207765-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207765-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207765-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207765-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207765-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207765-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207765-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207765-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207765-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207765-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207765-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207765-001	AB	1	`e64feba35796…`

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	COLESEVELAM	Zydus Lifesciences Limited	090eabd5-acd3-43ed-a05b-52f1f3773a93	2024-11-26		Exact identifier ndc (package): 70771-1368-2 ndc (package): 70771-1368-0 ndc (package): 70771-1368-8 ndc (package): 70771-1368-4 ndc (product): 70771-1368 ndc11 (package): 70771136804 ndc11 (package): 70771136800 ndc11 (package): 70771136802 ndc11 (package): 70771136808 spl id: 8bd17f3d-9ca2-4ce2-93a1-b4e9d8571079 spl set id: 090eabd5-acd3-43ed-a05b-52f1f3773a93

Reported adverse events (FAERS/openFDA)#

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