FDA.reportPublic FDA data

Ampicillin sodium

Product NDC
72485-422
11-digit product format
724850422
Labeler code
72485
Product ID
72485-422_4596759f-66c6-5801-e063-6394a90a9879
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA201025
Marketing category
ANDA
Marketing start
2023-04-25
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 sodium
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
72485-422-01Ampicillin sodium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION13
72485-422-10Ampicillin sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-422-01EA - Each72485-422260dc282-09eb-4237-982f-9c07a00c24d012023-06-06
72485-422-10EA - Each72485-422c05417e9-354f-4958-952e-67121272865112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-422AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION AMPICILLIN INJECTION, POWDER, FOR SOLUTION [ARMAS PHARMACEUTICALS INC.]2Current NDC, 2 package rows20231111_34e95c91-3767-493c-8716-38e61e7c6674.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721475ampicillin 1 GM InjectionPSN34e95c91-3767-493c-8716-38e61e7c66743
1721476ampicillin 2 GM InjectionPSN34e95c91-3767-493c-8716-38e61e7c66743
1721475ampicillin 1000 MG InjectionSCD34e95c91-3767-493c-8716-38e61e7c66743
1721476ampicillin 2000 MG InjectionSCD34e95c91-3767-493c-8716-38e61e7c66743
1721475ampicillin (as ampicillin sodium) 1 GM InjectionSY34e95c91-3767-493c-8716-38e61e7c66743
1721476ampicillin (as ampicillin sodium) 2 GM InjectionSY34e95c91-3767-493c-8716-38e61e7c66743
1721475ampicillin 1 GM InjectionSY34e95c91-3767-493c-8716-38e61e7c66743
1721476ampicillin 2 GM InjectionSY34e95c91-3767-493c-8716-38e61e7c66743
1721476ampicillin 2 GM InjectionPSN402e7cc7-5ae8-c113-e063-6394a90aa54a1
1721476ampicillin 2000 MG InjectionSCD402e7cc7-5ae8-c113-e063-6394a90aa54a1
1721476ampicillin (as ampicillin sodium) 2 GM InjectionSY402e7cc7-5ae8-c113-e063-6394a90aa54a1
1721476ampicillin 2 GM InjectionSY402e7cc7-5ae8-c113-e063-6394a90aa54a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-422-01724850422011 in 1 VIALHistorical
72485-422-107248504221010 VIAL in 1 CARTON (72485-422-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-422-01) 10 vial2023-04-25NoNoHistorical