COLESTIPOL HYDROCHLORIDE

Product NDC: 0115-2142
11-digit product format: 001152142
Labeler code: 0115
Product ID: 0115-2142_64268362-73d9-44bd-b56a-00164facfe60
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: COLESTIPOL HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA077510
Marketing category: ANDA
Marketing start: 2021-08-17
Marketing end: 0000-00-00
Substance: COLESTIPOL HYDROCHLORIDE
Active strength: 1 g/1
Pharmacologic classes: Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0115-2142		D	Discontinued by firm	2026-08-17
excluded package	package	0115-2142	0115-2142-02	D	Discontinued by firm	2026-08-17
excluded package	package	0115-2142	0115-2142-16	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-2142-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-2142-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0115-2142-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0115-2142-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0115-2142-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0115-2142-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0115-2142-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0115-2142-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0115-2142-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0115-2142-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0115-2142-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0115-2142-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0115-2142-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0115-2142-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0115-2142-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0115-2142-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0115-2142-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0115-2142-02	`0efc9e666f02…`	`f202fb6c5f17…`

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
A077510-001	COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077510-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2006-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2006-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2006-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2006-10-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2006-10-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2006-10-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2006-10-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2006-10-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2006-10-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2006-10-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2006-10-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2006-10-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077510-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2006-10-24	`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	A077510-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077510-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077510-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077510-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077510-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077510-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077510-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077510-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077510-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077510-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077510-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077510-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077510-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077510-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077510-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077510-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077510-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077510-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077510-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077510-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077510-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077510-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077510-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077510-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077510-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077510-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077510-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077510-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077510-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077510-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077510-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077510-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077510-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077510-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077510-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077510-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077510-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077510-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077510-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077510-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-2142-16	EA - Each	0115-2142	5c319e41-a224-443d-9a97-8d3519705bf2	1	2021-10-08

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
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	fa6c3e11-84e9-433d-aa74-7cd34336bbed	2026-05-21	Adverse reactions	Exact identifier application applno (ANDA): 077510 application number: ANDA077510
Colestipol Hydrochloride	COLESTIPOL HYDROCHLORIDE	American Health Packaging	153e9154-1804-4d73-94b7-a31a1d37c420	2025-10-01	Adverse reactions	Exact identifier application applno (ANDA): 077510 application number: ANDA077510

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X7D10K905G	COLESTIPOL HYDROCHLORIDE	37296-80-3	COLESTIPOL HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-2142-02	00115214202	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-2142-02)	2021-08-17	0000-00-00	No	No	Current
0115-2142-16	00115214216	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-2142-16)	2021-08-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colestipol Hydrochloride Tablets, USP (1 gram) Rx only	Amneal Pharmaceuticals of New York LLC	2021-05-11	HUMAN PRESCRIPTION DRUG LABEL	3