FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiX7D10K905G
Rxcui1048450

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

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