FDA.reportPublic FDA data

Ampicillin and Sulbactam

Product NDC
44567-211
Requested package NDC
44567-211-10
11-digit product format
445670211
Labeler code
44567
Product ID
44567-211_208d5891-64b3-4c0d-9191-1394bd00ae93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin and Sulbactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA065176
Marketing category
ANDA
Marketing start
2005-11-30
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
2; 1 g/20mL; g/20mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065176-001AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2005-11-30
A065176-002AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2005-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065176-001AP
A065176-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A065176-001AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2005-11-30a50c72e98297…
2026-08-01 22:54:322026-06A065176-002AMPICILLIN AND SULBACTAMEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2005-11-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065176-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A065176-002AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC9a722de6-9dc0-4fb9-b63a-225385aa33142026-06-23Warnings, Adverse reactionsExact identifier
ndc (package): 44567-211-10
ndc (product): 44567-211
ndc11 (package): 44567021110

Additional Listing Data#

Finished product
Yes
Brand name base
Ampicillin and Sulbactam
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JFN36L5S8KInternal UNII lookup
DKQ4T82YE6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1659592Internal RxNorm lookup
1659598Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9a722de6-9dc0-4fb9-b63a-225385aa3314Available on FDA.report

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
44567-211-10Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1020
44567-211-10Ampicillin and Sulbactam20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION2020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-211-10EA - Each44567-211c987475b-14a8-421e-9e97-a3e6c5c8795312013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPICILLIN SODIUMACTIVE INGREDIENTJFN36L5S8KAMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]5
SULBACTAM SODIUMACTIVE INGREDIENTDKQ4T82YE6AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]5
AMPICILLINACTIVE MOIETY7C782967RDAMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]5
SULBACTAMACTIVE MOIETYS4TF6I2330AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-211AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]19Current NDC, Legacy NDC, 2 package rows20250510_9a722de6-9dc0-4fb9-b63a-225385aa3314.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659592ampicillin / sulbactam 1.5 GM InjectionPSN9a722de6-9dc0-4fb9-b63a-225385aa331420
1659598ampicillin / sulbactam 3 GM InjectionPSN9a722de6-9dc0-4fb9-b63a-225385aa331420
1659592ampicillin 1000 MG / sulbactam 500 MG InjectionSCD9a722de6-9dc0-4fb9-b63a-225385aa331420
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCD9a722de6-9dc0-4fb9-b63a-225385aa331420
1659592ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM InjectionSY9a722de6-9dc0-4fb9-b63a-225385aa331420
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSY9a722de6-9dc0-4fb9-b63a-225385aa331420
1659592ampicillin 1 GM / sulbactam 0.5 GM InjectionSY9a722de6-9dc0-4fb9-b63a-225385aa331420
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSY9a722de6-9dc0-4fb9-b63a-225385aa331420

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-211-104456702111010 VIAL in 1 CARTON (44567-211-10) / 20 mL in 1 VIAL10 vial2005-11-300000-00-00NoNoCurrent