FDA.reportPublic FDA data

Ampicillin

Product NDC
0781-3409
11-digit product format
007813409
Labeler code
0781
Product ID
0781-3409_ca309c9e-8236-47fb-a0dd-2c2231b98650
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA061395
Marketing category
ANDA
Marketing start
1971-03-03
Substance
AMPICILLIN SODIUM
Active strength
10 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 SODIUM10 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFN36L5S8K
Rxcui789980

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
0781-3409-46Ampicillin1 in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION120
0781-3409-95Ampicillin10 in 1 PACKAGEINJECTION, POWDER, FOR SOLUTION1020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3409-46EA - Each0781-340929292cf6-f38e-46a2-bfbb-3fd125a6b15c12014-05-02
0781-3409-95EA - Each0781-34092d887bba-dc56-4333-951b-44d59c8070da12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPICILLIN SODIUMACTIVE INGREDIENTJFN36L5S8KAMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]13
AMPICILLINACTIVE MOIETY7C782967RDAMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3409AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]19Current NDC, Legacy NDC, 2 package rows20240518_6632a5bd-45f1-422f-80b0-46e5a628969a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
789980ampicillin 100 MG/ML Injectable SolutionPSN6632a5bd-45f1-422f-80b0-46e5a628969a20
789980ampicillin 100 MG/ML Injectable SolutionSCD6632a5bd-45f1-422f-80b0-46e5a628969a20
789980ampicillin (as ampicillin sodium) 100 MG/ML Injectable SolutionSY6632a5bd-45f1-422f-80b0-46e5a628969a20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3409-46007813409461 in 1 VIAL, PHARMACY BULK PACKAGEHistorical
0781-3409-950078134099510 VIAL, PHARMACY BULK PACKAGE in 1 PACKAGE (0781-3409-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3409-46) 1971-03-030000-00-00NoNoCurrent