FDA.reportPublic FDA data

Penicillin G Potassium

Product NDC
25021-153
11-digit product format
250210153
Labeler code
25021
Product ID
25021-153_0474a791-61f5-4da7-96db-63fa6541f87e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
penicillin g potassium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA065448
Marketing category
ANDA
Marketing start
2024-12-01
Substance
PENICILLIN G POTASSIUM
Active strength
5000000 [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 POTASSIUM5000000 [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
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
25021-153-20Penicillin G Potassium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102
25021-153-20Penicillin G Potassium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-153-20EA - Each25021-153b03d8b60-788e-4be7-958a-86fe290e388012025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-153PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]2Current NDC, 2 package rows20241208_fb2f3afe-0072-4383-bad8-9da9e94db4f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionPSNfb2f3afe-0072-4383-bad8-9da9e94db4f22
863538penicillin G potassium 1000000 UNT/ML Injectable SolutionSCDfb2f3afe-0072-4383-bad8-9da9e94db4f22
863538Penicillin G K+ 1000000 UNT/ML Injectable SolutionSYfb2f3afe-0072-4383-bad8-9da9e94db4f22
863538Penicillin G Pot 1000000 UNT/ML Injectable SolutionSYfb2f3afe-0072-4383-bad8-9da9e94db4f22
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionSYfb2f3afe-0072-4383-bad8-9da9e94db4f22
863538penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable SolutionSYfb2f3afe-0072-4383-bad8-9da9e94db4f22
863538penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable SolutionSYfb2f3afe-0072-4383-bad8-9da9e94db4f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-153-202502101532010 VIAL in 1 CARTON (25021-153-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2024-12-01NoNoCurrent