FDA.reportPublic FDA data

Colestipol hydrochloride

Product NDC
70710-1467
11-digit product format
707101467
Labeler code
70710
Product ID
70710-1467_f8cd3220-beeb-49b7-845a-d1bbb0476377
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colestipol hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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
70710-1467-5Colestipol hydrochloride500 in 1 BOTTLETABLET, FILM COATED5004
70710-1467-7Colestipol hydrochloride120 in 1 BOTTLETABLET, FILM COATED1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1467-7EA - Each70710-1467ca797cde-bb2f-45a0-87e7-6d9e667a487c12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1467COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20240220_71f12e0d-373a-4867-b37c-f24d99c5ce95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1048445colestipol HCl 1 GM Oral TabletPSN71f12e0d-373a-4867-b37c-f24d99c5ce954
1048445colestipol hydrochloride 1000 MG Oral TabletSCD71f12e0d-373a-4867-b37c-f24d99c5ce954
1048445colestipol hydrochloride 1 GM Oral TabletSY71f12e0d-373a-4867-b37c-f24d99c5ce954

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70710-1467-570710146705500 TABLET, FILM COATED in 1 BOTTLE (70710-1467-5) 2022-05-040000-00-00NoNoCurrent
70710-1467-770710146707120 TABLET, FILM COATED in 1 BOTTLE (70710-1467-7) 2022-05-040000-00-00NoNoCurrent