FDA.reportPublic FDA data

Penicillin G Potassium

Product NDC
70860-127
11-digit product format
708600127
Labeler code
70860
Product ID
70860-127_2cc9e113-4939-08d2-e063-6294a90ad0e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
penicillin g potassium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA065448
Marketing category
ANDA
Marketing start
2019-05-21
Marketing end
2027-05-31
Substance
PENICILLIN G POTASSIUM
Active strength
20000000 [iU]/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Penicillin G Potassium

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-127-512024-03-05C16284748780-11030e365-492b-111a-e063-dadaa90a10e2Penicillin G Potassium for Injection, USP
70860-127-512024-01-30C16284748780-11030e365-492b-111a-e063-dadaa90a10e2Penicillin G Potassium for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70860-127-51Penicillin G Potassium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION13
70860-127-51Penicillin G Potassium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-127-51EA - Each70860-127b0eb4a2c-db04-4fd8-a703-4c34659e881512019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-127PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]3Current NDC, Legacy NDC, 2 package rows20250130_1442486a-05d6-4dce-8b95-857a30f478c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionPSN1442486a-05d6-4dce-8b95-857a30f478c23
863538penicillin G potassium 1000000 UNT/ML Injectable SolutionSCD1442486a-05d6-4dce-8b95-857a30f478c23
863538Penicillin G K+ 1000000 UNT/ML Injectable SolutionSY1442486a-05d6-4dce-8b95-857a30f478c23
863538Penicillin G Pot 1000000 UNT/ML Injectable SolutionSY1442486a-05d6-4dce-8b95-857a30f478c23
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionSY1442486a-05d6-4dce-8b95-857a30f478c23
863538penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable SolutionSY1442486a-05d6-4dce-8b95-857a30f478c23
863538penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable SolutionSY1442486a-05d6-4dce-8b95-857a30f478c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-127-51708600127511 VIAL in 1 CARTON (70860-127-51) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL1 vial2019-05-212027-05-31NoNoCurrent