FDA.reportPublic FDA data

Colestipol Hydrochloride

Product NDC
60687-715
11-digit product format
606870715
Labeler code
60687
Product ID
60687-715_401f73b1-98f5-b6d1-e063-6394a90acf6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colestipol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077510
Marketing category
ANDA
Marketing start
2023-05-10
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
60687-715-11Colestipol Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED15
60687-715-21Colestipol Hydrochloride30 in 1 CARTONTABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-715-11EA - Each60687-715b8b23a1f-1bab-4f03-94e2-5e4fd0236e2a12023-04-07
60687-715-21EA - Each60687-715c2201bd2-b1a4-44a9-ad83-c78e56a54f1c12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-715COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4Current NDC, 2 package rows20250104_153e9154-1804-4d73-94b7-a31a1d37c420.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1048445colestipol HCl 1 GM Oral TabletPSN153e9154-1804-4d73-94b7-a31a1d37c4205
1048445colestipol hydrochloride 1000 MG Oral TabletSCD153e9154-1804-4d73-94b7-a31a1d37c4205
1048445colestipol hydrochloride 1 GM Oral TabletSY153e9154-1804-4d73-94b7-a31a1d37c4205

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-715-11606870715111 in 1 BLISTER PACKHistorical
60687-715-216068707152130 BLISTER PACK in 1 CARTON (60687-715-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-715-11) 30 blister pack2023-05-10NoNoHistorical