FDA.reportPublic FDA data

Ampicillin and Sulbactam

Product NDC
72603-335
11-digit product format
726030335
Labeler code
72603
Product ID
72603-335_c9fe0e6e-db1d-49ec-a16b-aa1de5ae7d5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin sodium and Sulbactam sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
NorthStar Rx, LLC
Application
ANDA065222
Marketing category
ANDA
Marketing start
2024-03-01
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
2; 1 g/1; g/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ampicillin and Sulbactam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPICILLIN SODIUM2 g/1
SULBACTAM SODIUM1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDKQ4T82YE6, JFN36L5S8K
Rxcui1659592, 1659598

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9d6ee0-43ae-43c7-aa52-3d5a936186d6Product name120250722
1f6437d4-fe6e-4912-889c-84576c1da4d8Product name120231019
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
72603-335-01Ampicillin and Sulbactam1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION12
72603-335-10Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102
72603-335-10Ampicillin and Sulbactam1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-335-01EA - Each72603-3358018c275-bf94-4481-beab-dcf39f6ec79012024-07-12
72603-335-10EA - Each72603-335ec72885c-81fa-498d-ae6a-6d6c7106b7d312024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-335AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RX, LLC]2Current NDC, 3 package rows20240628_1e5004f1-e79e-4e0b-9f3f-25f6bbc15255.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659592ampicillin / sulbactam 1.5 GM InjectionPSN1e5004f1-e79e-4e0b-9f3f-25f6bbc152552
1659598ampicillin / sulbactam 3 GM InjectionPSN1e5004f1-e79e-4e0b-9f3f-25f6bbc152552
1659592ampicillin 1000 MG / sulbactam 500 MG InjectionSCD1e5004f1-e79e-4e0b-9f3f-25f6bbc152552
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCD1e5004f1-e79e-4e0b-9f3f-25f6bbc152552
1659592ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM InjectionSY1e5004f1-e79e-4e0b-9f3f-25f6bbc152552
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSY1e5004f1-e79e-4e0b-9f3f-25f6bbc152552
1659592ampicillin 1 GM / sulbactam 0.5 GM InjectionSY1e5004f1-e79e-4e0b-9f3f-25f6bbc152552
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSY1e5004f1-e79e-4e0b-9f3f-25f6bbc152552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-335-01726030335011 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-335-01) 2024-03-01NoNoCurrent
72603-335-107260303351010 VIAL, SINGLE-DOSE in 1 CARTON (72603-335-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2024-03-01NoNoCurrent