Colestipol Hydrochloride Tablets, USP

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 21:18:15

Label at a glance#

ProductColestipol hydrochloride

Active ingredientCOLESTIPOL HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colestipol hydrochloride tablets, 1 g

120 tablets

NDC 70771-1653-7

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1048445	colestipol HCl 1 GM Oral Tablet	PSN	5
1048445	colestipol hydrochloride 1000 MG Oral Tablet	SCD	5
1048445	colestipol hydrochloride 1 GM Oral Tablet	SY	5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7ee3fbbc-8b06-ecd3-0995-c8769bc203d2	Product name	4	20250317
a2f9a12b-9d1e-48b5-8706-66d8e6a71a3b	Product name	1	20180626

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70771-1653-5	Colestipol hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500		5
70771-1653-7	Colestipol hydrochloride	120 in 1 BOTTLE	TABLET, FILM COATED	120		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1653	COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20241128_3b451f0b-5bd9-419a-afa2-a02eb0bbc45e.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Colestipol hydrochloride
COLESTIPOL
CELLACEFATE
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE, UNSPECIFIED
FERRIC OXIDE YELLOW
HYPROMELLOSES
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
TRIACETIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1653	70771-1653-7, 70771-1653-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
COLESTIPOL HYDROCHLORIDE	X7D10K905G	ACTIB
CELLACEFATE	F2O5O2OI9F	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CROSPOVIDONE, UNSPECIFIED	2S7830E561	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TRIACETIN	XHX3C3X673	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 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
A215223-001	COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2022-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215223-001	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.

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	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215223-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2022-03-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215223-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215223-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215223-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215223-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215223-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215223-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215223-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215223-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215223-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215223-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215223-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215223-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215223-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215223-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215223-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215223-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215223-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215223-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215223-001	AB	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215223-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215223-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215223-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215223-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215223-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215223-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215223-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215223-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215223-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215223-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215223-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215223-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215223-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215223-001	AB	1	`a50c72e98297…`

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
Colestipol hydrochloride	COLESTIPOL HYDROCHLORIDE	Zydus Lifesciences Limited	3b451f0b-5bd9-419a-afa2-a02eb0bbc45e	2024-11-26		Exact identifier ndc (package): 70771-1653-7 ndc (package): 70771-1653-5 ndc (product): 70771-1653 ndc11 (package): 70771165307 ndc11 (package): 70771165305 spl id: e5237070-d3ba-4dd6-921d-7ec80d8bc251 spl set id: 3b451f0b-5bd9-419a-afa2-a02eb0bbc45e

Reported adverse events (FAERS/openFDA)#

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