Prescription Drug Information: Penicillin V Potassium (Page 2 of 2)

HOW SUPPLIED

Penicillin V Potassium Tablets USP, 250 mg (400,000 units) are white to off-white, round shaped, biconvex, film-coated tablets debossed with ‘E’ and ’84’ on one side and break line on the other side.
Bottles of 100 NDC 57237-040-01
Bottles of 1,000 NDC 57237-040-99

Penicillin V Potassium Tablets USP, 500 mg (800,000 units) are white to off-white, capsule shaped, film-coated tablets, debossed with ‘E’ and a break line on one side and ‘8’ and ‘5’ separated with a break line on the other side.
Bottles of 100 NDC 57237-041-01
Bottles of 500 NDC 57237-041-05
Bottles of 1,000 NDC 57237-041-99

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Dispense in a tight container, as defined in the USP.
Keep tightly closed.
Keep out of reach of children.

REFERENCES

1. American Heart Association.1984. Prevention of bacterial endocarditis. Circulation 70(6):1123A – 1127A.


Distributed by:
Rising Health, LLC
Saddle Brook, NJ 07663
Made in India
Code: TS/DRUGS/57/2003
Revised: 09/2018

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 250 mg (100 Tablet Bottle)

Rising® NDC 57237-040-01
Penicillin V
Potassium
Tablets, USP
250 mg (400,000 Units)
100 Tablets Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 250 mg (100 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (100 Tablet Bottle)

Rising® NDC 57237-041-01
Penicillin V
Potassium
Tablets, USP
500 mg (800,000 Units)
100 Tablets Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg (100 Tablet Bottle)
(click image for full-size original)

PENICILLIN V POTASSIUM penicillin v potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-040
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIN V POTASSIUM (PENICILLIN V) PENICILLIN V 250 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K90
MICROCRYSTALLINE CELLULOSE
TALC
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape ROUND (Biconvex) Size 10mm
Flavor Imprint Code E;84
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-040-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57237-040-99 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065435 04/29/2008
PENICILLIN V POTASSIUM penicillin v potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-041
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIN V POTASSIUM (PENICILLIN V) PENICILLIN V 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K90
MICROCRYSTALLINE CELLULOSE
TALC
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape CAPSULE Size 17mm
Flavor Imprint Code E;8;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-041-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57237-041-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:57237-041-99 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065435 04/29/2008
Labeler — Rising Health, LLC (080500961)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917683 ANALYSIS (57237-040), ANALYSIS (57237-041), MANUFACTURE (57237-040), MANUFACTURE (57237-041)

Revised: 10/2022 Rising Health, LLC

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