FDA.reportPublic FDA data

Ampicillin

Product NDC
65219-014
11-digit product format
652190014
Labeler code
65219
Product ID
65219-014_38c6c088-e4ab-4859-b4d9-89e846cf9d5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ampicillin sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA062719
Marketing category
ANDA
Marketing start
2019-10-30
Substance
AMPICILLIN SODIUM
Active strength
250 mg/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
Ampicillin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPICILLIN SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFN36L5S8K
Rxcui1721473, 1721474, 1721475, 1721476

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9d6ee0-43ae-43c7-aa52-3d5a936186d6Product name120250722
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3Product name220160201
c9385d77-2af7-47a4-bc97-1127e71caf9bProduct name320160201
05b6b9ae-4ba4-27ee-4c8c-f72b41de3815Product name520151207
b353113e-7b3d-4b1f-a286-b96a3a5eac85Product name320151026
8c59be9b-72b0-49e8-b7ef-1a80c10599deProduct name320150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-014-01Ampicillin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION17
65219-014-10Ampicillin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-014-01EA - Each65219-014d66d55c9-0001-4c73-b1f5-edc7a020ff6712019-09-05
65219-014-10EA - Each65219-014eb233648-95ab-43d8-ba98-6ea386a2883712019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-014AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 2 package rows20221027_8dbb4c71-8543-08f1-e053-2995a90af88d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721475ampicillin 1 GM InjectionPSN8dbb4c71-8543-08f1-e053-2995a90af88d7
1721476ampicillin 2 GM InjectionPSN8dbb4c71-8543-08f1-e053-2995a90af88d7
1721473ampicillin 250 MG InjectionPSN8dbb4c71-8543-08f1-e053-2995a90af88d7
1721474ampicillin 500 MG InjectionPSN8dbb4c71-8543-08f1-e053-2995a90af88d7
1721475ampicillin 1000 MG InjectionSCD8dbb4c71-8543-08f1-e053-2995a90af88d7
1721476ampicillin 2000 MG InjectionSCD8dbb4c71-8543-08f1-e053-2995a90af88d7
1721473ampicillin 250 MG InjectionSCD8dbb4c71-8543-08f1-e053-2995a90af88d7
1721474ampicillin 500 MG InjectionSCD8dbb4c71-8543-08f1-e053-2995a90af88d7
1721475ampicillin (as ampicillin sodium) 1 GM InjectionSY8dbb4c71-8543-08f1-e053-2995a90af88d7
1721476ampicillin (as ampicillin sodium) 2 GM InjectionSY8dbb4c71-8543-08f1-e053-2995a90af88d7
1721473ampicillin (as ampicillin sodium) 250 MG InjectionSY8dbb4c71-8543-08f1-e053-2995a90af88d7
1721474ampicillin (as ampicillin sodium) 500 MG InjectionSY8dbb4c71-8543-08f1-e053-2995a90af88d7
1721475ampicillin 1 GM InjectionSY8dbb4c71-8543-08f1-e053-2995a90af88d7
1721476ampicillin 2 GM InjectionSY8dbb4c71-8543-08f1-e053-2995a90af88d7
1721473ampicillin 250 MG InjectionPSNe47a21b1-bbdb-4321-e053-2a95a90a3b4a3
1721473ampicillin 250 MG InjectionSCDe47a21b1-bbdb-4321-e053-2a95a90a3b4a3
1721473ampicillin (as ampicillin sodium) 250 MG InjectionSYe47a21b1-bbdb-4321-e053-2a95a90a3b4a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-014-01652190014011 in 1 VIALHistorical
65219-014-106521900141010 VIAL in 1 CARTON (65219-014-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-014-01) 10 vial2019-10-300000-00-00NoNoCurrent