Colestipol Hydrochloride

Product NDC
59762-0260
11-digit product format
597620260
Labeler code
59762
Product ID
59762-0260_a0444824-730e-4e63-9ddf-54461b1c4900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colestipol Hydrochloride
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA017563
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1977-04-04
Substance
COLESTIPOL HYDROCHLORIDE
Active strength
5 g/5g
Pharmacologic classes
Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017563-001FLAVORED COLESTIDCOLESTIPOL HYDROCHLORIDE5GM/PACKETGRANULE / ORALRLD, Approved before 1982
N017563-002FLAVORED COLESTIDCOLESTIPOL HYDROCHLORIDE5GM/SCOOPFULGRANULE / ORALRLD, Approved before 1982
N017563-003COLESTIDCOLESTIPOL HYDROCHLORIDE5GM/SCOOPFULGRANULE / ORALRLD1995-09-22
N017563-004COLESTIDCOLESTIPOL HYDROCHLORIDE5GM/PACKETGRANULE / ORALRLD, RS1995-09-22

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N017563-001FLAVORED COLESTID5GM/PACKETGRANULE / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017563-002FLAVORED COLESTID5GM/SCOOPFULGRANULE / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017563-003COLESTID5GM/SCOOPFULGRANULE / ORALRLD1995-09-22caaa826d4ba7…
2026-08-18 06:07:402026-07N017563-004COLESTID5GM/PACKETGRANULE / ORALRLD, RS1995-09-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017563-001FLAVORED COLESTID5GM/PACKETGRANULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017563-002FLAVORED COLESTID5GM/SCOOPFULGRANULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017563-003COLESTID5GM/SCOOPFULGRANULE / ORALABRLD1995-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017563-004COLESTID5GM/PACKETGRANULE / ORALABRLD, RS1995-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017563-001FLAVORED COLESTID5GM/PACKETGRANULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017563-002FLAVORED COLESTID5GM/SCOOPFULGRANULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017563-003COLESTID5GM/SCOOPFULGRANULE / ORALABRLD1995-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017563-004COLESTID5GM/PACKETGRANULE / ORALABRLD, RS1995-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017563-001FLAVORED COLESTID5GM/PACKETGRANULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017563-002FLAVORED COLESTID5GM/SCOOPFULGRANULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017563-003COLESTID5GM/SCOOPFULGRANULE / ORALABRLD1995-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017563-004COLESTID5GM/PACKETGRANULE / ORALABRLD, RS1995-09-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017563-001FLAVORED COLESTID5GM/PACKETGRANULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017563-002FLAVORED COLESTID5GM/SCOOPFULGRANULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017563-003COLESTID5GM/SCOOPFULGRANULE / ORALABRLD1995-09-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017563-004COLESTID5GM/PACKETGRANULE / ORALABRLD, RS1995-09-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017563-001FLAVORED COLESTID5GM/PACKETGRANULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017563-002FLAVORED COLESTID5GM/SCOOPFULGRANULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017563-003COLESTID5GM/SCOOPFULGRANULE / ORALABRLD1995-09-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017563-004COLESTID5GM/PACKETGRANULE / ORALABRLD, RS1995-09-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017563-001FLAVORED COLESTID5GM/PACKETGRANULE / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017563-002FLAVORED COLESTID5GM/SCOOPFULGRANULE / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017563-003COLESTID5GM/SCOOPFULGRANULE / ORALABRLD1995-09-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017563-004COLESTID5GM/PACKETGRANULE / ORALABRLD, RS1995-09-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017563-001FLAVORED COLESTID5GM/PACKETGRANULE / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017563-002FLAVORED COLESTID5GM/SCOOPFULGRANULE / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017563-003COLESTID5GM/SCOOPFULGRANULE / ORALABRLD1995-09-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017563-004COLESTID5GM/PACKETGRANULE / ORALABRLD, RS1995-09-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017563-001FLAVORED COLESTID5GM/PACKETGRANULE / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017563-002FLAVORED COLESTID5GM/SCOOPFULGRANULE / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017563-003COLESTID5GM/SCOOPFULGRANULE / ORALABRLD1995-09-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017563-004COLESTID5GM/PACKETGRANULE / ORALABRLD, RS1995-09-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017563-001FLAVORED COLESTID5GM/PACKETGRANULE / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017563-002FLAVORED COLESTID5GM/SCOOPFULGRANULE / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017563-003COLESTID5GM/SCOOPFULGRANULE / ORALABRLD1995-09-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017563-004COLESTID5GM/PACKETGRANULE / ORALABRLD, RS1995-09-22d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N017563-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017563-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017563-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017563-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017563-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017563-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017563-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017563-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017563-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017563-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017563-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017563-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017563-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017563-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017563-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017563-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017563-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017563-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017563-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017563-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017563-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017563-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017563-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017563-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017563-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017563-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017563-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017563-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017563-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017563-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017563-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017563-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017563-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017563-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017563-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017563-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017563-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N017563-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017563-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N017563-004AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Colestipol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLESTIPOL HYDROCHLORIDE5 g/5g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X7D10K905GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1048450Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e89bf6e-c78a-402e-9cb2-8d02f6047d68Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7ee3fbbc-8b06-ecd3-0995-c8769bc203d2Product name420250317
a2f9a12b-9d1e-48b5-8706-66d8e6a71a3bProduct name120180626

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-0260-1Colestipol Hydrochloride30 in 1 CARTONGRANULE, FOR SUSPENSION3011
59762-0260-1Colestipol Hydrochloride5 g in 1 PACKETGRANULE, FOR SUSPENSION511
59762-0260-2Colestipol Hydrochloride5 g in 1 PACKETGRANULE, FOR SUSPENSION511
59762-0260-2Colestipol Hydrochloride90 in 1 CARTONGRANULE, FOR SUSPENSION9011
59762-0260-3Colestipol Hydrochloride500 g in 1 BOTTLEGRANULE, FOR SUSPENSION50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0260-1EA - Each59762-0260871198ea-954b-41f9-a2c3-7d113ce34e0612016-02-04
59762-0260-2EA - Each59762-02605bf000c9-1ccb-42f1-bb15-af6e2b859d6612016-02-04
59762-0260-3GM - Gram59762-0260d0126b35-b7f6-4877-96fb-b4c868a597ce12016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0260COLESTIPOL HYDROCHLORIDE GRANULE, FOR SUSPENSION [MYLAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 5 package rows20250509_4e89bf6e-c78a-402e-9cb2-8d02f6047d68.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colestipol HydrochlorideCOLESTIPOL HYDROCHLORIDEMylan Pharmaceuticals Inc.4e89bf6e-c78a-402e-9cb2-8d02f6047d682025-05-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 017563
application number: NDA017563
ndc (product): 59762-0260
ColestidCOLESTIPOL HYDROCHLORIDEPharmacia & Upjohn Company LLC21b37725-fc0c-4365-a7dc-1a473d42502d2024-06-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 017563
application number: NDA017563

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1048450colestipol HCl 5 GM Granules For Oral SuspensionPSN4e89bf6e-c78a-402e-9cb2-8d02f6047d6811
1048450colestipol hydrochloride 5000 MG Granules for Oral SuspensionSCD4e89bf6e-c78a-402e-9cb2-8d02f6047d6811
1048450colestipol hydrochloride 5 GM Granules For Oral SuspensionSY4e89bf6e-c78a-402e-9cb2-8d02f6047d6811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-0260-15976202600130 PACKET in 1 CARTON (59762-0260-1) / 5 g in 1 PACKET30 packet1977-04-042027-05-31NoNoCurrent
59762-0260-25976202600290 PACKET in 1 CARTON (59762-0260-2) / 5 g in 1 PACKET90 packet1977-04-042026-10-31NoNoCurrent
59762-0260-359762026003500 g in 1 BOTTLE (59762-0260-3) 500 g1977-04-040000-00-00NoNoCurrent