FDA.reportPublic FDA data

Colestipol Hydrochloride

Product NDC
59762-0450
11-digit product format
597620450
Labeler code
59762
Product ID
59762-0450_1b610c4a-a8dc-4a10-bd7a-3e94ca49ee9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colestipol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA020222
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1994-07-19
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
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 HYDROCHLORIDE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX7D10K905G
Rxcui1048445

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
59762-0450-1Colestipol Hydrochloride120 in 1 BOTTLETABLET12012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0450-1EA - Each59762-0450c535b088-cc52-4dab-a540-e570546afa6c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLESTIPOL HYDROCHLORIDEACTIVE INGREDIENTX7D10K905GCOLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC]4
COLESTIPOLACTIVE MOIETYK50N755924COLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCOLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC]4
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC]4
TRIACETININACTIVE INGREDIENTXHX3C3X673COLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC]4
COLESTIPOL HYDROCHLORIDEACTIVE INGREDIENTX7D10K905GCOLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
COLESTIPOLACTIVE MOIETYK50N755924COLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCOLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
TRIACETININACTIVE INGREDIENTXHX3C3X673COLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
COLESTIPOL HYDROCHLORIDEACTIVE INGREDIENTX7D10K905GCOLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
COLESTIPOLACTIVE MOIETYK50N755924COLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCOLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECOLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673COLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0450COLESTIPOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 1 package rows20250515_dae7d51e-c117-4c8a-b018-45b01ae46100.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1048445colestipol HCl 1 GM Oral TabletPSNdae7d51e-c117-4c8a-b018-45b01ae4610012
1048445colestipol hydrochloride 1000 MG Oral TabletSCDdae7d51e-c117-4c8a-b018-45b01ae4610012
1048445colestipol hydrochloride 1 GM Oral TabletSYdae7d51e-c117-4c8a-b018-45b01ae4610012
1048445colestipol HCl 1 GM Oral TabletPSNfbd848be-fb6a-495c-80bc-a9e9ed18e15f3
1048445colestipol hydrochloride 1000 MG Oral TabletSCDfbd848be-fb6a-495c-80bc-a9e9ed18e15f3
1048445colestipol hydrochloride 1 GM Oral TabletSYfbd848be-fb6a-495c-80bc-a9e9ed18e15f3
1048445colestipol HCl 1 GM Oral TabletPSNece20a8d-3d58-4f4a-8a96-348cfdf8392e1
1048445colestipol hydrochloride 1000 MG Oral TabletSCDece20a8d-3d58-4f4a-8a96-348cfdf8392e1
1048445colestipol hydrochloride 1 GM Oral TabletSYece20a8d-3d58-4f4a-8a96-348cfdf8392e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-0450-159762045001120 TABLET in 1 BOTTLE (59762-0450-1) 120 tablet1994-07-190000-00-00NoNoCurrent