Ampicillin and Sulbactam

Product NDC
71288-032
11-digit product format
712880032
Labeler code
71288
Product ID
71288-032_0104f04f-ad00-4d3d-8107-907c6fd4ab77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin sodium and Sulbactam sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA065222
Marketing category
ANDA
Marketing start
2005-11-29
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
71288-032-20Ampicillin and Sulbactam1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION16
71288-032-21Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION106
71288-032-91Ampicillin and Sulbactam1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION12
71288-032-92Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-032-20EA - Each71288-032c59c99a0-5c81-44d2-97d1-bd9c5aed4fbc12023-09-05
71288-032-21EA - Each71288-03274bcf4b8-1edd-4a63-9e0e-8bdd0b9b72b312023-09-05
71288-032-91EA - Each71288-032c73a0bb5-55c6-46a5-a0e8-63fd01c3ba9012024-09-09
71288-032-92EA - Each71288-0320424c762-97b7-4a94-855d-641937c38b6012024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-032AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]6Current NDC, 2 package rows20250323_e6cf14a8-3ed9-4a7a-ba69-be0b794cbdc4.zip
71288-032AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240524_006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659592ampicillin / sulbactam 1.5 GM InjectionPSNe6cf14a8-3ed9-4a7a-ba69-be0b794cbdc46
1659598ampicillin / sulbactam 3 GM InjectionPSNe6cf14a8-3ed9-4a7a-ba69-be0b794cbdc46
1659592ampicillin 1000 MG / sulbactam 500 MG InjectionSCDe6cf14a8-3ed9-4a7a-ba69-be0b794cbdc46
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCDe6cf14a8-3ed9-4a7a-ba69-be0b794cbdc46
1659592ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM InjectionSYe6cf14a8-3ed9-4a7a-ba69-be0b794cbdc46
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSYe6cf14a8-3ed9-4a7a-ba69-be0b794cbdc46
1659592ampicillin 1 GM / sulbactam 0.5 GM InjectionSYe6cf14a8-3ed9-4a7a-ba69-be0b794cbdc46
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSYe6cf14a8-3ed9-4a7a-ba69-be0b794cbdc46
1659592ampicillin / sulbactam 1.5 GM InjectionPSN006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2
1659598ampicillin / sulbactam 3 GM InjectionPSN006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2
1659592ampicillin 1000 MG / sulbactam 500 MG InjectionSCD006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCD006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2
1659592ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM InjectionSY006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSY006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2
1659592ampicillin 1 GM / sulbactam 0.5 GM InjectionSY006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSY006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-032-20712880032201 in 1 VIAL, SINGLE-DOSEHistorical
71288-032-217128800322110 VIAL, SINGLE-DOSE in 1 CARTON (71288-032-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-032-20) 2005-11-29NoNoCurrent
71288-032-91712880032911 in 1 VIAL, SINGLE-DOSEHistorical
71288-032-927128800329210 VIAL, SINGLE-DOSE in 1 CARTON (71288-032-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-032-91) 2005-11-29NoNoCurrent