COLESTIPOL HYDROCHLORIDE

Product NDC: 72603-817
Requested package NDC: 72603-817-01
11-digit product format: 726030817
Labeler code: 72603
Product ID: 72603-817_515f9c9d-c91c-f5ac-e063-6294a90a2f3d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: COLESTIPOL HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA216517
Marketing category: ANDA
Marketing start: 2026-09-01
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: 2027-12-31
Current FDA listing: Yes

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
A216517-001	COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB		2023-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216517-001	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	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216517-001	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2023-03-10	`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	A216517-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216517-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216517-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216517-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216517-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216517-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216517-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216517-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216517-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216517-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216517-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216517-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216517-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216517-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216517-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216517-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216517-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216517-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216517-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216517-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216517-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216517-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216517-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216517-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216517-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: COLESTIPOL HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
COLESTIPOL HYDROCHLORIDE	1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X7D10K905G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1048445	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
515f9b07-7c03-0a2b-e063-6394a90a617d	Available on FDA.report

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	NorthStar Rx LLC	515f9b07-7c03-0a2b-e063-6394a90a617d	2026-06-02	Adverse reactions	Exact identifier application applno (ANDA): 216517 application number: ANDA216517 ndc (package): 72603-817-01 ndc (product): 72603-817 ndc11 (package): 72603081701
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	3d380b5e-e346-4a47-ac95-faa37c6f2a51	2025-09-12	Adverse reactions	Exact identifier application applno (ANDA): 216517 application number: ANDA216517

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	Sample	Exclude flag	Status
72603-817-01	72603081701	120 TABLET, FILM COATED in 1 BOTTLE (72603-817-01)	2026-09-01	No	No	Current