NDC Code(s) : 0009-0260-01, 0009-0260-04, 0009-0260-17, 0009-0260-02, 0009-0370-03, 0009-0370-05
Packager : Pharmacia & Upjohn Company LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ColestidColestipol Hydrochloride GRANULE, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-0260
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLESTIPOL HYDROCHLORIDE(UNII: X7D10K905G)
(COLESTIPOL - UNII:K50N755924) 		COLESTIPOL HYDROCHLORIDE5 g in 5 g
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0009-0260-0130 in 1 CARTON 06/01/1977
15 g in 1 PACKET Type 0: Not a Combination Product
2NDC:0009-0260-0490 in 1 CARTON 06/01/1977
25 g in 1 PACKET Type 0: Not a Combination Product
3NDC:0009-0260-171 in 1 CARTON 06/01/1977
3300 g in 1 BOTTLE Type 1: Convenience Kit of Co-Package
4NDC:0009-0260-021 in 1 CARTON 06/01/1977
4500 g in 1 BOTTLE Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017563 06/01/1977
Flavored ColestidColestipol Hydrochloride GRANULE, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-0370
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLESTIPOL HYDROCHLORIDE(UNII: X7D10K905G)
(COLESTIPOL - UNII:K50N755924) 		COLESTIPOL HYDROCHLORIDE5 g in 7.5 g
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ASPARTAME(UNII: Z0H242BBR1)
BETA CAROTENE(UNII: 01YAE03M7J)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
MALTOL(UNII: 3A9RD92BS4)
MANNITOL(UNII: 3OWL53L36A)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0009-0370-032 in 1 CARTON 06/01/1977
160 in 1 CARTON
17.5 g in 1 PACKET Type 0: Not a Combination Product
2NDC:0009-0370-051 in 1 CARTON 06/01/1977
2450 g in 1 BOTTLE Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017563 06/01/1977 04/30/2024

LABELER - Pharmacia & Upjohn Company LLC(618054084)

Establishment
Name Address ID/FEI Business Operations
Pharmacia & Upjohn Company LLC 618054084 ANALYSIS(0009-0260, 0009-0370), API MANUFACTURE(0009-0260, 0009-0370), LABEL(0009-0260, 0009-0370), MANUFACTURE(0009-0260), PACK(0009-0260, 0009-0370)

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0009-0260-01

Colestid ®
colestipol hydrochloride
for oral suspension, USP

5 grams
Rx only

PRINCIPAL DISPLAY PANEL - 5 gram Packet Label

PRINCIPAL DISPLAY PANEL

NDC 0009-0260-01

Pfizer
Colestid ®
colestipol
hydrochloride
for oral suspension, USP

30 Foil Packets – 5 grams each
Rx only

PRINCIPAL DISPLAY PANEL - 5 gram Packet Carton

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0009-0260-17

Colestid ®

colestipol hydrochloride
for oral suspension, USP

300 grams
Rx only

PRINCIPAL DISPLAY PANEL - 300 gram Bottle Label

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0009-0260-17

Colestid ®

colestipol hydrochloride
for oral suspension, USP

300 grams
Rx only

PRINCIPAL DISPLAY PANEL - 300 gram Bottle Carton

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0009-0370-03

Flavored Colestid ®
colestipol hydrochloride
for oral suspension

7.5 grams powder containing 5 grams
of colestipol hydrochloride

NUTRASWEET®
BRAND SWEETENER*

Phenylketonurics: contains phenylalanine
18.2 mg per 7.5 grams

Rx only

PRINCIPAL DISPLAY PANEL - 7.5 gram Packet Label

PRINCIPAL DISPLAY PANEL

NOT TO BE SOLD SEPARATELY
NDC 0009-0370-03

Pfizer
Flavored Colestid ®
colestipol hydrochloride
for oral suspension

7.5 grams powder containing 5 grams of
colestipol hydrochloride per packet

NUTRASWEET®
BRAND SWEETENER*

Phenylketonurics: contains phenylalanine
18.2 mg per 7.5 grams

30 packets (One of Two Cartons)
Rx only

PRINCIPAL DISPLAY PANEL - 30-7.5 gram Packet Carton

PRINCIPAL DISPLAY PANEL

NDC 0009-0370-03

Pfizer
Flavored Colestid ®
colestipol hydrochloride
for oral suspension

7.5 grams powder containing 5 grams of
colestipol hydrochloride per packet

NUTRASWEET®
BRAND SWEETENER*

Phenylketonurics: contains phenylalanine
18.2 mg per 7.5 grams

60 packets
Rx only

PRINCIPAL DISPLAY PANEL - 60-7.5 gram Packet Carton

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0009-0370-05

Flavored Colestid ®
colestipol hydrochloride
for oral suspension

7.5 grams powder containing 5 grams
of colestipol hydrochloride per scoop

NUTRASWEET®
BRAND SWEETENER*

Phenylketonurics: contains
phenylalanine 18.2 mg per 7.5 grams

450 grams (60 scoops of 7.5 grams each)

Rx only

PRINCIPAL DISPLAY PANEL - 450 gram Bottle Label

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0009-0370-05

Flavored Colestid ®
colestipol hydrochloride
for oral suspension

7.5 grams powder containing
5 grams of colestipol hydrochloride
per scoop

NUTRASWEET®
BRAND SWEETENER*

Phenylketonurics: contains
phenylalanine 18.2 mg per 7.5 grams

450 grams (60 scoops of 7.5 grams each)

Rx only

PRINCIPAL DISPLAY PANEL - 450 gram Bottle Carton