FDA.reportPublic FDA data

Colestid

Product NDC
0009-0260
11-digit product format
000090260
Labeler code
0009
Product ID
0009-0260_c3fec1ea-1280-462f-b320-3753ddc3d42b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colestipol Hydrochloride
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA017563
Marketing category
NDA
Marketing start
1977-06-01
Substance
COLESTIPOL HYDROCHLORIDE
Active strength
5 g/5g
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
Colestid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLESTIPOL HYDROCHLORIDE5 g/5g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX7D10K905G
Rxcui1048450, 1048452

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7ee3fbbc-8b06-ecd3-0995-c8769bc203d2Product name420250317
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
a2f9a12b-9d1e-48b5-8706-66d8e6a71a3bProduct name120180626
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-0260-01Colestid5 g in 1 PACKETGRANULE, FOR SUSPENSION514
0009-0260-01Colestid30 in 1 CARTONGRANULE, FOR SUSPENSION3014
0009-0260-02Colestid1 in 1 CARTONGRANULE, FOR SUSPENSION114
0009-0260-02Colestid500 g in 1 BOTTLEGRANULE, FOR SUSPENSION50014
0009-0260-04Colestid90 in 1 CARTONGRANULE, FOR SUSPENSION9014
0009-0260-04Colestid5 g in 1 PACKETGRANULE, FOR SUSPENSION514
0009-0260-17Colestid300 g in 1 BOTTLEGRANULE, FOR SUSPENSION30014
0009-0260-17Colestid1 in 1 CARTONGRANULE, FOR SUSPENSION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0260-01EA - Each0009-02605fe3162b-7ede-476b-a150-4fd6cfbea33b12012-07-24
0009-0260-02GM - Gram0009-026069139403-d320-4f0e-90d1-0b04a7a9ab5a12012-07-24
0009-0260-04EA - Each0009-0260de6d985c-89bb-4643-8e93-afef5785188812012-07-24
0009-0260-17GM - Gram0009-026064578f7b-b3df-448c-a50e-5279fe7acb7912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLESTIPOL HYDROCHLORIDEACTIVE INGREDIENTX7D10K905GCOLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION FLAVORED COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
COLESTIPOLACTIVE MOIETYK50N755924COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION FLAVORED COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
.BETA.-CAROTENEINACTIVE INGREDIENT01YAE03M7JCOLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION FLAVORED COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION FLAVORED COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCOLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION FLAVORED COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
MALTOLINACTIVE INGREDIENT3A9RD92BS4COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION FLAVORED COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
MANNITOLINACTIVE INGREDIENT3OWL53L36ACOLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION FLAVORED COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION FLAVORED COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0260COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION FLAVORED COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION [PHARMACIA & UPJOHN COMPANY LLC]14Current NDC, Legacy NDC, 8 package rows20240629_21b37725-fc0c-4365-a7dc-1a473d42502d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1048452Colestid 5 GM Granules For Oral SuspensionPSN21b37725-fc0c-4365-a7dc-1a473d42502d14
1048450colestipol HCl 5 GM Granules For Oral SuspensionPSN21b37725-fc0c-4365-a7dc-1a473d42502d14
1048452colestipol hydrochloride 5000 MG Granules for Oral Suspension [Colestid]SBD21b37725-fc0c-4365-a7dc-1a473d42502d14
1048450colestipol hydrochloride 5000 MG Granules for Oral SuspensionSCD21b37725-fc0c-4365-a7dc-1a473d42502d14
1048452Colestid 5 GM Granules For Oral SuspensionSY21b37725-fc0c-4365-a7dc-1a473d42502d14
1048452Colestid 5000 MG Oral Granules For Oral SuspensionSY21b37725-fc0c-4365-a7dc-1a473d42502d14
1048450colestipol hydrochloride 5 GM Granules For Oral SuspensionSY21b37725-fc0c-4365-a7dc-1a473d42502d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0260-010000902600130 PACKET in 1 CARTON (0009-0260-01) > 5 g in 1 PACKET30 packet1977-04-040000-00-00NoNoCurrent
0009-0260-02000090260021 BOTTLE in 1 CARTON (0009-0260-02) / 500 g in 1 BOTTLE1 bottle1977-06-010000-00-00NoNoCurrent
0009-0260-040000902600490 PACKET in 1 CARTON (0009-0260-04) > 5 g in 1 PACKET90 packet1977-04-040000-00-00NoNoCurrent
0009-0260-17000090260171 BOTTLE in 1 CARTON (0009-0260-17) / 300 g in 1 BOTTLE1 bottle1977-06-010000-00-00NoNoCurrent