Penicillin G Potassium (Page 5 of 5)

HOW SUPPLIED

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)

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.

1989 Sexually transmitted diseases treatment guidelines. MMWR 38(S-8); 5-14, Sept. 1, 1989.

Clinitest^® is a registered trademark of Miles, Inc.

Clinistix^® is a registered trademark of Bayer Corporation.

Revised: September 2020

46276384

46276385

Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540

5 million unit Label

NDC 0781-6135-95 Rx Only

Buffered Penicillin G

Potassium for

Injection, USP

5,000,000 Units*

(5 million units)

For IM or IV use

10 Vials

SANDOZ

20 million unit Label

NDC 0781-6136-94

Buffered

Penicillin G

Potassium for

Injection, USP

20,000,000 Units*

(20 million units)

For IV use

Rx Only

1 Vial

SANDOZ – A Novartis Division

PENICILLIN G POTASSIUM penicillin g potassium injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-6135 Route of Administration INTRAVENOUS, INTRAMUSCULAR 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:0781-6135-95 10 VIAL in 1 CARTON contains a VIAL (0781-6135-94) 1 NDC:0781-6135-94 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (0781-6135-95)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065079 08/30/2001

PENICILLIN G POTASSIUM penicillin g potassium injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-6136 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIN G POTASSIUM (PENICILLIN G) PENICILLIN G 20000000 [iU]

Inactive Ingredients Ingredient Name Strength SODIUM CITRATE, UNSPECIFIED FORM CITRIC ACID MONOHYDRATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0781-6136-94 1 VIAL in 1 CARTON contains a VIAL 1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (0781-6136-94)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065079 08/30/2001

Labeler — Sandoz Inc (005387188)

Revised: 09/2020 Sandoz Inc