FDA.reportPublic FDA data

COLESTIPOL HYDROCHLORIDE

Product NDC
0115-5212
11-digit product format
001155212
Labeler code
0115
Product ID
0115-5212_78f0e0f5-e61e-4c11-8e35-b65bcdfcfc06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
COLESTIPOL HYDROCHLORIDE
Dosage form
SUSPENSION
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA077277
Marketing category
ANDA
Marketing start
2006-05-02
Substance
COLESTIPOL HYDROCHLORIDE
Active strength
5 g/1
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/1

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
0115-5212-18COLESTIPOL HYDROCHLORIDE30 in 1 CARTONSUSPENSION3012
0115-5212-29COLESTIPOL HYDROCHLORIDE90 in 1 CARTONSUSPENSION9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-5212-18EA - Each0115-5212f1a177c7-fc99-427d-8f83-2e80c23bbf5d12012-07-24
0115-5212-29EA - Each0115-5212c2a29f94-d96d-49ec-a177-016926df9d6812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLESTIPOL HYDROCHLORIDEACTIVE INGREDIENTX7D10K905GCOLESTIPOL HYDROCHLORIDE SUSPENSION [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3
COLESTIPOLACTIVE MOIETYK50N755924COLESTIPOL HYDROCHLORIDE SUSPENSION [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLESTIPOL HYDROCHLORIDE SUSPENSION [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-5212COLESTIPOL HYDROCHLORIDE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]12Current NDC, Legacy NDC, 2 package rows20231231_839354bd-cbac-4d18-8c02-b1b93766af38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1048450colestipol HCl 5 GM Granules For Oral SuspensionPSN839354bd-cbac-4d18-8c02-b1b93766af3812
1048450colestipol hydrochloride 5000 MG Granules for Oral SuspensionSCD839354bd-cbac-4d18-8c02-b1b93766af3812
1048450colestipol hydrochloride 5 GM Granules For Oral SuspensionSY839354bd-cbac-4d18-8c02-b1b93766af3812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-5212-180011552121830 SUSPENSION in 1 CARTON (0115-5212-18) 30 suspension2006-05-020000-00-00NoNoCurrent
0115-5212-290011552122990 SUSPENSION in 1 CARTON (0115-5212-29) 90 suspension2006-05-020000-00-00NoNoCurrent