BUFFERED PENICILLIN G POTASSIUM (Page 4 of 4)

HOW SUPPLIED

BUFFERED PENICILLIN G POTASSIUM FOR INJECTION, USP is supplied in the following dosage forms.
NDC 51662-1436-1
BUFFERED PENICILLIN G POTASSIUM FOR INJECTION, USP 5,000,000 UNITS (5 MILLION UNITS)

HF Acquisition Co LLC, DBA HealthFirst
Mukilteo, WA 98275

Also supplied in the following manufacture supplied dosage forms

Buffered Penicillin G Potassium for Injection, USP, is supplied in dry powder form in vials containing 1,000,000 units (1 million units) × 10’s (NDC 0781-6134-95), 5,000,000 units (5 million units) × 10’s (NDC 0781-6135-95), and 20,000,000 units (20 million units) × 1’s (NDC 0781-6136-94) of crystalline penicillin G as the potassium salt; buffered with sodium citrate and citric acid to an optimum pH.

STORAGE

Store the dry powder at 20° to 25°C (68° to 77°F) [see USP controlled room temperature].

Sterile constituted solution may be kept in refrigerator 2° to 8°C (36° to 46°F) for 7 days without significant loss of potency.

REFERENCES

1.National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests – Fourth Edition. Tentative Standard NCCLS Document M2-T4, Vol. 8, No. 7, NCCLS, Villanova, PA, 1988.
2.
National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Second Edition. Tentative Standard NCCLS Document M7-T2, Vol. 8, No. 8. NCCLS, Villanova, PA, 1988.
3.
National Committee for Clinical Laboratory Standards, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria – Second Edition. Tentative Standard NCCLS Document M11-T2, Villanova, PA, 1988 (or current M11-A2).
4.
1989 Sexually transmitted diseases treatment guidelines. MMWR 38(S-8); 5-14, Sept. 1, 1989.

SPL UNCLASSIFIED

03-2015M

46158430

46158432

Manufactured in Austria by Sandoz GmbH

for Sandoz Inc., Princeton, NJ 08540

PRINCIPAL DISPLAY PANEL — VIAL LABEL

VIAL LABEL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — SERIALIZED LABELING

SERIALIZED LABELING
(click image for full-size original)

BUFFERED PENICILLIN G POTASSIUM
buffered penicillin g potassium injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1436(NDC:0781-6135)
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIN G POTASSIUM (PENICILLIN G) PENICILLIN G 5000000 [iU]
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE, UNSPECIFIED FORM
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1436-1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065079 01/29/2020
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1436)

Revised: 02/2020 HF Acquisition Co LLC, DBA HealthFirst

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