FDA.reportPublic FDA data

Ampicillin

Product NDC
72603-578
11-digit product format
726030578
Labeler code
72603
Product ID
72603-578_ded2f0fe-8fdf-4ec1-ad0d-1f5ddc15cba5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
NorthStar Rx, LLC
Application
ANDA201404
Marketing category
ANDA
Marketing start
2024-03-01
Substance
AMPICILLIN SODIUM
Active strength
10 g/100mL
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/100mL

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
72603-578-01Ampicillin100 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION1001
72603-578-01Ampicillin10 in 1 BOXINJECTION, POWDER, FOR SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-578-01EA - Each72603-578cb2d7574-997a-4913-8eeb-a75908bf01ce12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-578AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RX, LLC]1Current NDC, 2 package rows20240301_3b683547-48ac-48ca-8fd4-6866fd17be34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
789980ampicillin 100 MG/ML Injectable SolutionPSN3b683547-48ac-48ca-8fd4-6866fd17be341
789980ampicillin 100 MG/ML Injectable SolutionSCD3b683547-48ac-48ca-8fd4-6866fd17be341
789980ampicillin (as ampicillin sodium) 100 MG/ML Injectable SolutionSY3b683547-48ac-48ca-8fd4-6866fd17be341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-578-017260305780110 VIAL, PHARMACY BULK PACKAGE in 1 BOX (72603-578-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE2024-03-01NoNoCurrent