Pfizerpen

Product NDC
0049-0420
11-digit product format
000490420
Labeler code
0049
Product ID
0049-0420_9bbe1112-d804-49de-bdff-245ce94872f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
penicillin G potassium
Dosage form
POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAPLEURAL; INTRATHECAL; INTRAVENOUS
Labeler
Roerig
Application
ANDA060657
Marketing category
ANDA
Marketing start
2010-06-01
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
Pfizerpen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLIN G POTASSIUM5000000 [iU]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVL775ZTH4C
Rxcui863538, 995906

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
0049-0420-05Pfizerpen1 in 1 VIALPOWDER, FOR SOLUTION19
0049-0420-10Pfizerpen10 in 1 CARTONPOWDER, FOR SOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-0420-05EA - Each0049-0420aca2658c-ef06-499b-b379-51e580aa5bf812018-04-19
0049-0420-10EA - Each0049-0420edf1e408-c0be-485b-9838-b11c3fa9d87912018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-0420PFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]9Current NDC, Legacy NDC, 2 package rows20241215_2f7ea103-56cc-492f-b862-af45f9aed980.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionPSN2f7ea103-56cc-492f-b862-af45f9aed9809
995906Pfizerpen 1,000,000 UNT/ML Injectable SolutionPSN2f7ea103-56cc-492f-b862-af45f9aed9809
995906penicillin G potassium 1000000 UNT/ML Injectable Solution [Pfizerpen]SBD2f7ea103-56cc-492f-b862-af45f9aed9809
863538penicillin G potassium 1000000 UNT/ML Injectable SolutionSCD2f7ea103-56cc-492f-b862-af45f9aed9809
863538Penicillin G K+ 1000000 UNT/ML Injectable SolutionSY2f7ea103-56cc-492f-b862-af45f9aed9809
995906Penicillin G K+ 1000000 UNT/ML Injectable Solution [Pfizerpen]SY2f7ea103-56cc-492f-b862-af45f9aed9809
863538Penicillin G Pot 1000000 UNT/ML Injectable SolutionSY2f7ea103-56cc-492f-b862-af45f9aed9809
995906Penicillin G Pot 1000000 UNT/ML Injectable Solution [Pfizerpen]SY2f7ea103-56cc-492f-b862-af45f9aed9809
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionSY2f7ea103-56cc-492f-b862-af45f9aed9809
863538penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable SolutionSY2f7ea103-56cc-492f-b862-af45f9aed9809
863538penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable SolutionSY2f7ea103-56cc-492f-b862-af45f9aed9809
995906Pfizerpen 1,000,000 UNT/ML Injectable SolutionSY2f7ea103-56cc-492f-b862-af45f9aed9809

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-0420-05000490420051 in 1 VIALHistorical
0049-0420-100004904201010 VIAL in 1 CARTON (0049-0420-10) / 1 POWDER, FOR SOLUTION in 1 VIAL (0049-0420-05) 10 vial2018-03-300000-00-00NoNoCurrent