Penicillin G Potassium

Product NDC
83634-103
11-digit product format
836340103
Labeler code
83634
Product ID
83634-103_727994cd-436d-4347-a023-5a861abd3264
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
penicillin g potassium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Avenacy Inc.
Application
ANDA065448
Marketing category
ANDA
Marketing start
2025-02-01
Substance
PENICILLIN G POTASSIUM
Active strength
20000000 [iU]/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Penicillin G Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLIN G POTASSIUM20000000 [iU]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVL775ZTH4C
Rxcui863538

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea092e41-01a8-4781-b199-b94446808a52Product name120190205
af7816cd-473e-4681-8ef5-5d4b569ced61Product name120151014
b37c02b5-6cf5-47fd-aab5-d510a02bbac0Product name120151014
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0f47357f-4a94-e9f0-4fab-2eb6732c6263Product name120140508
11e45d82-8b7a-98b7-67b2-842a15f88536Product name120140508
6ccfe771-a97a-e261-3fb2-bf8e525d1fe0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83634-103-51Penicillin G Potassium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION11
83634-103-51Penicillin G Potassium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-103PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [AVENACY INC.]1Current NDC, 2 package rows20250201_969a421e-37d8-499e-9e89-67e210bd5d9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionPSN969a421e-37d8-499e-9e89-67e210bd5d9d1
863538penicillin G potassium 1000000 UNT/ML Injectable SolutionSCD969a421e-37d8-499e-9e89-67e210bd5d9d1
863538Penicillin G K+ 1000000 UNT/ML Injectable SolutionSY969a421e-37d8-499e-9e89-67e210bd5d9d1
863538Penicillin G Pot 1000000 UNT/ML Injectable SolutionSY969a421e-37d8-499e-9e89-67e210bd5d9d1
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionSY969a421e-37d8-499e-9e89-67e210bd5d9d1
863538penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable SolutionSY969a421e-37d8-499e-9e89-67e210bd5d9d1
863538penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable SolutionSY969a421e-37d8-499e-9e89-67e210bd5d9d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-103-51836340103511 VIAL in 1 CARTON (83634-103-51) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL1 vial2025-02-01NoNoCurrent