Colestipol hydrochloride

Product NDC
70771-1653
11-digit product format
707711653
Labeler code
70771
Product ID
70771-1653_e5237070-d3ba-4dd6-921d-7ec80d8bc251
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colestipol hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA215223
Marketing category
ANDA
Marketing start
2022-05-04
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
70771-1653-5Colestipol hydrochloride500 in 1 BOTTLETABLET, FILM COATED5005
70771-1653-7Colestipol hydrochloride120 in 1 BOTTLETABLET, FILM COATED1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1653COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 2 package rows20241128_3b451f0b-5bd9-419a-afa2-a02eb0bbc45e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1048445colestipol HCl 1 GM Oral TabletPSN3b451f0b-5bd9-419a-afa2-a02eb0bbc45e5
1048445colestipol hydrochloride 1000 MG Oral TabletSCD3b451f0b-5bd9-419a-afa2-a02eb0bbc45e5
1048445colestipol hydrochloride 1 GM Oral TabletSY3b451f0b-5bd9-419a-afa2-a02eb0bbc45e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1653-570771165305500 TABLET, FILM COATED in 1 BOTTLE (70771-1653-5) 2022-05-040000-00-00NoNoCurrent
70771-1653-770771165307120 TABLET, FILM COATED in 1 BOTTLE (70771-1653-7) 2022-05-040000-00-00NoNoCurrent