FDA.reportPublic FDA data

Penicillin G Sodium

Product NDC
0781-6153
11-digit product format
007816153
Labeler code
0781
Product ID
0781-6153_0e84343e-8796-4c54-8dcc-8448a231fcfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin G Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA065068
Marketing category
ANDA
Marketing start
2001-02-26
Substance
PENICILLIN G SODIUM
Active strength
5000000 [USP'U]/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 Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLIN G SODIUM5000000 [USP'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYS5LY7JF4N
Rxcui745302

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
0781-6153-94Penicillin G Sodium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION115
0781-6153-95Penicillin G Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1015
0781-6153-97Penicillin G Sodium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION115
0781-6153-97Penicillin G Sodium50 in 1 CARTONINJECTION, POWDER, FOR SOLUTION5015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-6153-94EA - Each0781-615310b6ce8e-7539-4407-a3b1-f7c5176249c612012-07-24
0781-6153-95EA - Each0781-61535e5d1c94-31d1-4902-83e1-d182746eb5cf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENICILLIN G SODIUMACTIVE INGREDIENTYS5LY7JF4NPENICILLIN G SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]12
PENICILLIN GACTIVE MOIETYQ42T66VG0CPENICILLIN G SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-6153PENICILLIN G SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]15Current NDC, Legacy NDC, 4 package rows20200605_23b6d4a3-b273-4e10-9da9-1376933fdbdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
745302penicillin G sodium 100,000 UNT/ML Injectable SolutionPSN23b6d4a3-b273-4e10-9da9-1376933fdbdf15
745302penicillin G sodium 100000 UNT/ML Injectable SolutionSCD23b6d4a3-b273-4e10-9da9-1376933fdbdf15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-6153-94007816153941 in 1 VIALHistorical
0781-6153-950078161539510 VIAL in 1 CARTON (0781-6153-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-6153-94) 10 vial2001-02-260000-00-00NoNoCurrent
0781-6153-97007816153971 in 1 VIALHistorical