FDA.reportPublic FDA data

Pfizerpen

Product NDC
0049-0530
11-digit product format
000490530
Labeler code
0049
Product ID
0049-0530_0fe9ce5c-e7dc-4526-ab48-6f910e721efd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
penicillin G potassium
Dosage form
POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Roerig
Application
ANDA060657
Marketing category
ANDA
Marketing start
2010-06-01
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
Pfizerpen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLIN G POTASSIUM20000000 [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
0049-0530-28Pfizerpen1 in 1 CARTONPOWDER, FOR SOLUTION126
0049-0530-28Pfizerpen1 in 1 VIALPOWDER, FOR SOLUTION126
0049-0530-22Pfizerpen1 in 1 VIALPOWDER, FOR SOLUTION121
0049-0530-22Pfizerpen1 in 1 CARTONPOWDER, FOR SOLUTION121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-0530-22EA - Each0049-05301c815bc8-b643-4ebd-a40c-e19c579b30a912012-07-24
0049-0530-28EA - Each0049-053095e6227f-1006-4d39-b821-a764e3a4bb3212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENICILLIN G POTASSIUMACTIVE INGREDIENTVL775ZTH4CPFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]9
PENICILLIN GACTIVE MOIETYQ42T66VG0CPFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]9
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]9
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]9
PENICILLIN G POTASSIUMACTIVE INGREDIENTVL775ZTH4CPFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]7
PENICILLIN GACTIVE MOIETYQ42T66VG0CPFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]7
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]7
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]7
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95LPFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-0530PFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]26Current NDC, Legacy NDC, 2 package rows20241213_d8aaefb6-3f7d-4bc5-b40a-1c58c3054320.zip
0049-0530PFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]20Current NDC, Legacy NDC, 2 package rows20241213_efef4846-9497-41af-8dd6-518f86eca7f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionPSNd8aaefb6-3f7d-4bc5-b40a-1c58c305432026
995906Pfizerpen 1,000,000 UNT/ML Injectable SolutionPSNd8aaefb6-3f7d-4bc5-b40a-1c58c305432026
995906penicillin G potassium 1000000 UNT/ML Injectable Solution [Pfizerpen]SBDd8aaefb6-3f7d-4bc5-b40a-1c58c305432026
863538penicillin G potassium 1000000 UNT/ML Injectable SolutionSCDd8aaefb6-3f7d-4bc5-b40a-1c58c305432026
863538Penicillin G K+ 1000000 UNT/ML Injectable SolutionSYd8aaefb6-3f7d-4bc5-b40a-1c58c305432026
995906Penicillin G K+ 1000000 UNT/ML Injectable Solution [Pfizerpen]SYd8aaefb6-3f7d-4bc5-b40a-1c58c305432026
863538Penicillin G Pot 1000000 UNT/ML Injectable SolutionSYd8aaefb6-3f7d-4bc5-b40a-1c58c305432026
995906Penicillin G Pot 1000000 UNT/ML Injectable Solution [Pfizerpen]SYd8aaefb6-3f7d-4bc5-b40a-1c58c305432026
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionSYd8aaefb6-3f7d-4bc5-b40a-1c58c305432026
863538penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable SolutionSYd8aaefb6-3f7d-4bc5-b40a-1c58c305432026
863538penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable SolutionSYd8aaefb6-3f7d-4bc5-b40a-1c58c305432026
995906Pfizerpen 1,000,000 UNT/ML Injectable SolutionSYd8aaefb6-3f7d-4bc5-b40a-1c58c305432026
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionPSNefef4846-9497-41af-8dd6-518f86eca7f221
995906Pfizerpen 1,000,000 UNT/ML Injectable SolutionPSNefef4846-9497-41af-8dd6-518f86eca7f221
995906penicillin G potassium 1000000 UNT/ML Injectable Solution [Pfizerpen]SBDefef4846-9497-41af-8dd6-518f86eca7f221
863538penicillin G potassium 1000000 UNT/ML Injectable SolutionSCDefef4846-9497-41af-8dd6-518f86eca7f221
863538Penicillin G K+ 1000000 UNT/ML Injectable SolutionSYefef4846-9497-41af-8dd6-518f86eca7f221
995906Penicillin G K+ 1000000 UNT/ML Injectable Solution [Pfizerpen]SYefef4846-9497-41af-8dd6-518f86eca7f221
863538Penicillin G Pot 1000000 UNT/ML Injectable SolutionSYefef4846-9497-41af-8dd6-518f86eca7f221
995906Penicillin G Pot 1000000 UNT/ML Injectable Solution [Pfizerpen]SYefef4846-9497-41af-8dd6-518f86eca7f221
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionSYefef4846-9497-41af-8dd6-518f86eca7f221
863538penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable SolutionSYefef4846-9497-41af-8dd6-518f86eca7f221
863538penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable SolutionSYefef4846-9497-41af-8dd6-518f86eca7f221
995906Pfizerpen 1,000,000 UNT/ML Injectable SolutionSYefef4846-9497-41af-8dd6-518f86eca7f221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-0530-22000490530221 VIAL in 1 CARTON (0049-0530-22) / 1 POWDER, FOR SOLUTION in 1 VIAL1 vial2010-06-010000-00-00NoNoCurrent
0049-0530-28000490530281 VIAL in 1 CARTON (0049-0530-28) / 1 POWDER, FOR SOLUTION in 1 VIAL1 vial2010-06-010000-00-00NoNoCurrent