Galantamine (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Galantamine Tablets USP, 4 mg (equivalent to 5.126 mg galantamine hydrobromide) are light-pink, round , biconvex, film-coated tablets debossed with ’77’ on one side and ‘Z’ on the other side and are supplied as follows:

NDC 68382-177-14 in bottle of 60 tablets

NDC 68382-177-01 in bottle of 100 tablets

NDC 68382-177-10 in bottle of 1,000 tablets

NDC 68382-177-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets

Galantamine Tablets USP, 8 mg (equivalent to 10.252 mg of galantamine hydrobromide) are off-white, round, biconvex, film-coated tablets debossed with ’78’ on one side and ‘Z’ on the other side and are supplied as follows:

NDC 68382-178-14 in bottle of 60 tablets

NDC 68382-178-01 in bottle of 100 tablets

NDC 68382-178-10 in bottle of 1,000 tablets

NDC 68382-178-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets

Galantamine Tablets USP, 12 mg (equivalent to 15.378 mg of galantamine hydrobromide) are off-white, round, biconvex, film-coated tablets debossed with ’79’ on one side and ‘Z’ on the other side and are supplied as follows:

NDC 68382-179-14 in bottle of 60 tablets

NDC 68382-179-01 in bottle of 100 tablets

NDC 68382-179-10 in bottle of 1,000 tablets

NDC 68382-179-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets

16.2 Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

Serious Skin Reactions

Advise patients and caregivers to discontinue galantamine and seek immediate medical attention at the first appearance of skin rash [see Warnings and Precautions (5.1)].

General Dosing Guidance

Instruct caregivers about the recommended dosage and administration of galantamine hydrobromide. Galantamine tablets should be administered twice per day, preferably with the morning and evening meals. Dose escalation (dose increases) should follow a minimum of four weeks at prior dose. If therapy has been interrupted for more than three days, the patient should be restarted with the lowest dose and then re-titrated to an appropriate dosage [see Dosage and Administration (2)].

Advise patients and caregivers to ensure adequate fluid intake during treatment [see Dosage and Administration (2)].

Advise patients and caregivers that the most frequent adverse events associated with use of the drug can be minimized by following the recommended dosage and administration.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev: 05/20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68382-177-14 in bottle of 60 tablets

Galantamine Tablets USP, 4 mg

Rx only

60 tablets

ZYDUS

galantamine tablets USP, 4mg
(click image for full-size original)

NDC 68382-178-14 in bottle of 60 tablets

Galantamine Tablets USP, 8 mg

Rx only

60 tablets

ZYDUS

galantamine Tablets USP, 8mg
(click image for full-size original)

NDC 68382-179-14 in bottle of 60 tablets

Galantamine Tablets USP, 12 mg

Rx only

60 tablets

ZYDUS

galantamine Tablets USP, 12mg
(click image for full-size original)
GALANTAMINE galantamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-177
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE (GALANTAMINE) GALANTAMINE 4 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FERRIC OXIDE RED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
TITANIUM DIOXIDE
SILICON DIOXIDE
Product Characteristics
Color PINK (LIGHT PINK) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code 77;Z
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-177-14 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68382-177-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68382-177-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68382-177-77 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-177-30)
4 NDC:68382-177-30 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (68382-177-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078898 10/10/2011
GALANTAMINE galantamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-178
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE (GALANTAMINE) GALANTAMINE 8 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
TITANIUM DIOXIDE
SILICON DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code 78;Z
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-178-14 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68382-178-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68382-178-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68382-178-77 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-178-30)
4 NDC:68382-178-30 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (68382-178-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078898 10/10/2011
GALANTAMINE galantamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-179
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE (GALANTAMINE) GALANTAMINE 12 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
TITANIUM DIOXIDE
HYPROMELLOSES
SILICON DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code 79;Z
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-179-14 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68382-179-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68382-179-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68382-179-77 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-179-30)
4 NDC:68382-179-30 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (68382-179-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078898 10/10/2011
Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945)
Registrant — Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (68382-177), ANALYSIS (68382-178), ANALYSIS (68382-179), MANUFACTURE (68382-177), MANUFACTURE (68382-178), MANUFACTURE (68382-179)

Revised: 05/2020 Zydus Pharmaceuticals (USA) Inc.

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