FDA.reportPublic FDA data

Ampicillin and Sulbactam

Product NDC
71288-033
11-digit product format
712880033
Labeler code
71288
Product ID
71288-033_3d2029ff-d114-4d0e-98b9-e90f1320e90e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin Sodium and Sulbactam Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA065314
Marketing category
ANDA
Marketing start
2006-11-27
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
10; 5 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 SODIUM10 g/1
SULBACTAM SODIUM5 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFN36L5S8K, DKQ4T82YE6
Rxcui240984

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
71288-033-75Ampicillin and Sulbactam1 in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION13
71288-033-75Ampicillin and Sulbactam1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION13
71288-033-91Ampicillin and Sulbactam1 in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION12
71288-033-91Ampicillin and Sulbactam1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-033-75EA - Each71288-033d4efd3b7-98f7-4b5b-87b8-49435a3fa89112024-03-12
71288-033-91EA - Each71288-0330d6b6bdc-654d-4cf9-bce1-292612a9bc7f12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-033AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]3Current NDC, 2 package rows20250507_139b4b2e-46f7-44a8-9cc1-774afa463b80.zip
71288-033AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240524_9f2ff165-2a21-4155-a4f0-57885a83c7dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240984ampicillin 100 MG / sulbactam 50 MG in ML Injectable SolutionPSN139b4b2e-46f7-44a8-9cc1-774afa463b803
240984ampicillin 100 MG/ML / sulbactam 50 MG/ML Injectable SolutionSCD139b4b2e-46f7-44a8-9cc1-774afa463b803
240984ampicillin (as ampicillin sodium) 10 GM / sulbactam (as sulbactam sodium) 5 GM per 100 ML Injectable SolutionSY139b4b2e-46f7-44a8-9cc1-774afa463b803
240984ampicillin (as ampicillin sodium) 100 MG/ML / sulbactam (as sulbactam sodium) 50 MG/ML Injectable SolutionSY139b4b2e-46f7-44a8-9cc1-774afa463b803
240984ampicillin 100 MG / sulbactam 50 MG in ML Injectable SolutionPSN9f2ff165-2a21-4155-a4f0-57885a83c7dc2
240984ampicillin 100 MG/ML / sulbactam 50 MG/ML Injectable SolutionSCD9f2ff165-2a21-4155-a4f0-57885a83c7dc2
240984ampicillin (as ampicillin sodium) 10 GM / sulbactam (as sulbactam sodium) 5 GM per 100 ML Injectable SolutionSY9f2ff165-2a21-4155-a4f0-57885a83c7dc2
240984ampicillin (as ampicillin sodium) 100 MG/ML / sulbactam (as sulbactam sodium) 50 MG/ML Injectable SolutionSY9f2ff165-2a21-4155-a4f0-57885a83c7dc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71288-033-75712880033751 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE1 bottle2006-11-27NoNoCurrent
71288-033-91712880033911 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE1 bottle2006-11-27NoNoCurrent