FDA.reportPublic FDA data

Ampicillin

Product NDC
0781-3413
11-digit product format
007813413
Labeler code
0781
Product ID
0781-3413_a4c2a8ec-b73a-43e3-ac67-4c6f0d0bef37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA062738
Marketing category
ANDA
Marketing start
1987-02-19
Substance
AMPICILLIN SODIUM
Active strength
2 g/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 SODIUM2 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFN36L5S8K
Rxcui1721475, 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
0781-3413-15Ampicillin1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION116
0781-3413-92Ampicillin10 in 1 PACKAGEINJECTION, POWDER, FOR SOLUTION1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3413-15EA - Each0781-3413037c4b21-81f7-4bce-9abc-1f8862fc72ac12012-07-24
0781-3413-92EA - Each0781-34133bda0677-cb13-4805-a522-30ab97c8899012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPICILLIN SODIUMACTIVE INGREDIENTJFN36L5S8KAMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]11
AMPICILLINACTIVE MOIETY7C782967RDAMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3413AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]16Current NDC, Legacy NDC, 2 package rows20250523_67dd2930-8482-4da5-b663-b751aff18c61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721475ampicillin 1 GM InjectionPSN67dd2930-8482-4da5-b663-b751aff18c6116
1721476ampicillin 2 GM InjectionPSN67dd2930-8482-4da5-b663-b751aff18c6116
1721475ampicillin 1000 MG InjectionSCD67dd2930-8482-4da5-b663-b751aff18c6116
1721476ampicillin 2000 MG InjectionSCD67dd2930-8482-4da5-b663-b751aff18c6116
1721475ampicillin (as ampicillin sodium) 1 GM InjectionSY67dd2930-8482-4da5-b663-b751aff18c6116
1721476ampicillin (as ampicillin sodium) 2 GM InjectionSY67dd2930-8482-4da5-b663-b751aff18c6116
1721475ampicillin 1 GM InjectionSY67dd2930-8482-4da5-b663-b751aff18c6116
1721476ampicillin 2 GM InjectionSY67dd2930-8482-4da5-b663-b751aff18c6116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3413-15007813413151 in 1 VIAL, GLASSHistorical
0781-3413-920078134139210 VIAL, GLASS in 1 PACKAGE (0781-3413-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0781-3413-15) 1987-02-190000-00-00NoNoCurrent