Procardia (Page 4 of 4)

Co-Administration with Other Antianginal Drugs

Sublingual nitroglycerin may be taken as required for the control of acute manifestations of angina, particularly during PROCARDIA titration. See PRECAUTIONS, Drug Interactions, for information on co-administration of PROCARDIA with beta blockers or long-acting nitrates.

HOW SUPPLIED

PROCARDIA soft gelatin capsules are supplied in:

Bottles of 100: 10 mg (NDC 0069-2600-66)

The capsules should be protected from light and moisture and stored at controlled room temperature, 59° to 77°F (15° to 25°C) in the manufacturer’s original container.

Logo

LAB-0178-7.0

July 2016

PRINCIPAL DISPLAY PANEL — 10 mg Capsule Bottle Label

Pfizer
NDC 0069-2600-66

Procardia ®
nifedipine

10 mg

Capsules

100 CapsulesRx only

PRINCIPAL DISPLAY PANEL -- 10 mg Capsule Bottle Label
(click image for full-size original)
PROCARDIA nifedipine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-2600
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIFEDIPINE (NIFEDIPINE) NIFEDIPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
PEPPERMINT OIL
POLYETHYLENE GLYCOL, UNSPECIFIED
FD&C YELLOW NO. 6
FERRIC OXIDE RED
WATER
SACCHARIN SODIUM
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code PROCARDIA;PFIZER;260
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-2600-66 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018482 12/31/1981 10/31/2021
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Operations
Pfizer Inc 943955690 ANALYSIS (0069-2600)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084545 ANALYSIS (0069-2600), MANUFACTURE (0069-2600), API MANUFACTURE (0069-2600)
Establishment
Name Address ID/FEI Operations
Pfizer Laboratories Div Pfizer Inc 001147495 ANALYSIS (0069-2600)

Revised: 06/2021 Pfizer Laboratories Div Pfizer Inc

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.