NDC Code(s) : 0009-5190-01, 0009-5190-02, 0009-5190-03, 0009-5190-04, 0009-5191-01, 0009-5191-02, 0009-5191-03, 0009-5191-04, 0009-5191-99
Packager : Pharmacia and Upjohn Company LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Detrol LAtolterodine tartrate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-5190
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLTERODINE TARTRATE(UNII: 5T619TQR3R)
(TOLTERODINE - UNII:WHE7A56U7K) 		TOLTERODINE TARTRATE2 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
OLEIC ACID(UNII: 2UMI9U37CP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color BLUE (Blue-green) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code 2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0009-5190-0130 in 1 BOTTLE Type 0: Not a Combination Product22/02/2000
2NDC:0009-5190-0290 in 1 BOTTLE Type 0: Not a Combination Product22/02/2000
3NDC:0009-5190-03500 in 1 BOTTLE Type 0: Not a Combination Product22/02/2000
4NDC:0009-5190-04100 in 1 CARTON 22/02/2000
41 in 1 BLISTER PACK Type 0: Not a Combination Product22/02/2000
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021228 02/22/2000 12/31/2024
Detrol LAtolterodine tartrate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-5191
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLTERODINE TARTRATE(UNII: 5T619TQR3R)
(TOLTERODINE - UNII:WHE7A56U7K) 		TOLTERODINE TARTRATE4 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
OLEIC ACID(UNII: 2UMI9U37CP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code 4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0009-5191-0130 in 1 BOTTLE Type 0: Not a Combination Product22/02/2000
2NDC:0009-5191-0290 in 1 BOTTLE Type 0: Not a Combination Product22/02/2000
3NDC:0009-5191-03500 in 1 BOTTLE Type 0: Not a Combination Product22/02/2000
4NDC:0009-5191-04100 in 1 CARTON 22/02/2000
41 in 1 BLISTER PACK Type 0: Not a Combination Product22/02/2000
5NDC:0009-5191-997 in 1 BOX, UNIT-DOSE Type 0: Not a Combination Product22/02/2000
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021228 02/22/2000 12/31/2024

LABELER - Pharmacia and Upjohn Company LLC(618054084)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 30 Capsule 2 mg Bottle Label

NDC 0009-5190-01

30 Capsules
Rx only

Detrol® LA
tolterodine tartrate
extended release capsules

2 mg

Pfizer
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL - 30 Capsule 2 mg Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 2 mg Capsule Dose Foil Pack

Detrol ® LA
tolterodine tartrate
extended release
Capsule

2 mg

Pharmacia & Upjohn Co
Div of Pfizer Inc, NY, NY 10017

13803100

PRINCIPAL DISPLAY PANEL - 2 mg Capsule Dose Foil Pack

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 2 mg Capsule Unit Dose Carton

UNIT DOSE

Pfizer
NDC 0009-5190-04

Detrol ® LA
tolterodine tartrate
extended release capsules

2 mg

For in-institution use only

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 2 mg Capsule Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 30 Capsule 4 mg Bottle Label

NDC 0009-5191-01

30 Capsules
Rx only

Detrol® LA
tolterodine tartrate
extended release capsules

4 mg

Pfizer
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL - 30 Capsule 4 mg Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 4 mg Capsule Dose Foil Pack

Detrol ® LA
tolterodine tartrate
extended release
Capsule

4 mg

Pharmacia & Upjohn Co
Div of Pfizer Inc, NY, NY 10017

13802700

PRINCIPAL DISPLAY PANEL - 4 mg Capsule Dose Foil Pack

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 4 mg Capsule Unit Dose Carton

UNIT DOSE

Pfizer
NDC 0009-5191-04

Detrol ® LA
tolterodine tartrate
extended release capsules

4 mg

For in-institution use only

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 4 mg Capsule Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 4 mg Capsule Sample Dose Pack

NDC 0009-5191-99

Detrol ® LA
tolterodine tartrate
extended release capsules

4 mg

Detrol ® LA
tolterodine tartrate
extended release capsules

4 mg

PROFESSIONAL
SAMPLE –
NOT FOR SALE

Protect from light

Detrol ® LA
tolterodine tartrate
extended release capsules

4 mg

Manufactured by:
Pfizer Pharmaceuticals LLC, Puerto Rico

Pfizer
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

11604800

Lot
Exp

PRINCIPAL DISPLAY PANEL - 4 mg Capsule Sample Dose Pack

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 4 mg Capsule Sample Carton

SEE ENCLOSED EDUCATIONAL BROCHURE
FOR MORE INFORMATION

PROFESSIONAL SAMPLE – NOT FOR SALE

NDC 0009-5191-99
Rx only

Detrol ® LA
tolterodine tartrate
extended release capsules

4 mg
7 capsules

FOR FREE INFORMATION, CALL 1-888-846-9034
OR VISIT OUR WEB SITE www.detrolLA.com

PRINCIPAL DISPLAY PANEL - 4 mg Capsule Sample Carton