FDA.reportPublic FDA data

Ampicillin and Sulbactam

Product NDC
43858-133
11-digit product format
438580133
Labeler code
43858
Product ID
43858-133_989a6b34-596b-4c83-88e5-efbfd4d36ee6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin sodium and Sulbactam sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz GmbH
Application
ANDA065310
Marketing category
ANDA
Marketing start
2006-07-25
Marketing end
0000-00-00
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
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
2021-12-31
Current FDA listing
Historical FDA.report record

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
A065310-001AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTION2006-07-25
A065310-002AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTION2006-07-25

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 22:54:322026-06A065310-001AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTION2006-07-25a50c72e98297…
2026-08-01 22:54:322026-06A065310-002AMPICILLIN AND SULBACTAMEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTION2006-07-25a50c72e98297…

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 SODIUM AND SULBACTAM SODIUMHospira, Incdc374fa4-350b-425d-a7db-7099fdc64cf12026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065310
application number: ANDA065310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43858-133-024385801330210 VIAL in 1 TRAY (43858-133-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2017-08-250000-00-00NoNoCurrent