FDA.reportPublic FDA data

Ampicillin

Product NDC
72603-454
11-digit product format
726030454
Labeler code
72603
Product ID
72603-454_ccfb8b44-c373-40a6-8fc9-afd9584e5970
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ampicillin sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
NorthStar Rx, LLC
Application
ANDA062797
Marketing category
ANDA
Marketing start
2024-03-01
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
Rxcui1721474, 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
72603-454-01Ampicillin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION11
72603-454-10Ampicillin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-454-01EA - Each72603-454280c1561-7eaa-437a-932f-b9dc3795f4af12024-07-12
72603-454-10EA - Each72603-45482615bb6-c476-4c9d-a815-bd261d10f27f12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-454AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RX, LLC]1Current NDC, 2 package rows20240301_6772d650-9814-49e4-a4ec-0b1a97b837d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721475ampicillin 1 GM InjectionPSN6772d650-9814-49e4-a4ec-0b1a97b837d11
1721476ampicillin 2 GM InjectionPSN6772d650-9814-49e4-a4ec-0b1a97b837d11
1721474ampicillin 500 MG InjectionPSN6772d650-9814-49e4-a4ec-0b1a97b837d11
1721475ampicillin 1000 MG InjectionSCD6772d650-9814-49e4-a4ec-0b1a97b837d11
1721476ampicillin 2000 MG InjectionSCD6772d650-9814-49e4-a4ec-0b1a97b837d11
1721474ampicillin 500 MG InjectionSCD6772d650-9814-49e4-a4ec-0b1a97b837d11
1721475ampicillin (as ampicillin sodium) 1 GM InjectionSY6772d650-9814-49e4-a4ec-0b1a97b837d11
1721476ampicillin (as ampicillin sodium) 2 GM InjectionSY6772d650-9814-49e4-a4ec-0b1a97b837d11
1721474ampicillin (as ampicillin sodium) 500 MG InjectionSY6772d650-9814-49e4-a4ec-0b1a97b837d11
1721475ampicillin 1 GM InjectionSY6772d650-9814-49e4-a4ec-0b1a97b837d11
1721476ampicillin 2 GM InjectionSY6772d650-9814-49e4-a4ec-0b1a97b837d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-454-01726030454011 in 1 VIALHistorical
72603-454-107260304541010 VIAL in 1 CARTON (72603-454-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72603-454-01) 10 vial2024-03-01NoNoCurrent