Vancomycin Hydrochloride (Page 4 of 4)

17 PATIENT COUNSELING INFORMATION

Severe Dermatologic Reactions

Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking Vancomycin Hydrochloride Capsules immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions or blisters [see Warnings and Precautions (5.5)].

Antibacterial Resistance

Patients should be counseled that antibacterial drugs including Vancomycin Hydrochloride Capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Vancomycin Hydrochloride Capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Vancomycin Hydrochloride Capsules or other antibacterial drugs in the future.

Manufactured by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
ani

Package/Label Display Panel

NDC 62559-390-20
Vancomycin Hydrochloride Capsules USP
125 mg*
Rx only
Not a Child Resistant Container
20 Capsules

Carton-125mg
(click image for full-size original)

Package/Label Display Panel

NDC 62559-391-20
Vancomycin Hydrochloride Capsules USP
250 mg*
Rx only
Not a Child Resistant Container
20 Capsules

Carton-250mg
(click image for full-size original)

VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-390
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 125 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
GELATIN, UNSPECIFIED
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 6000
TITANIUM DIOXIDE
Product Characteristics
Color BLUE, BROWN Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code 3125;VANCOCIN;HCL;125;MG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-390-20 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (62559-390-20)
2 NDC:62559-390-50 50 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA050606 10/26/2015
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-391
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 250 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
GELATIN, UNSPECIFIED
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOL 6000
TITANIUM DIOXIDE
Product Characteristics
Color BLUE, PURPLE (lavender) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code 3126;VANCOCIN;HCL;250;MG;
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-391-20 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (62559-391-20)
2 NDC:62559-391-50 50 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA050606 10/26/2015
Labeler — ANI Pharmaceuticals, Inc. (145588013)

Revised: 01/2022 ANI Pharmaceuticals, Inc.

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