FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
0781-3240
11-digit product format
007813240
Labeler code
0781
Product ID
0781-3240_ad3c44ea-73db-44d7-b11f-d1fa82d968e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA078252
Marketing category
ANDA
Marketing start
2008-03-24
Marketing end
0000-00-00
Substance
CIPROFLOXACIN
Active strength
2 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-3240DDiscontinued by firm2026-07-31
excluded packagepackage0781-32400781-3240-09DDiscontinued by firm2026-07-31

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
A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN200MG/100MLINJECTABLE / INJECTIONAP2008-03-18
A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN400MG/200MLINJECTABLE / INJECTIONAP2008-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078252-001AP
A078252-002AP

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 22:54:322026-06A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-18a50c72e98297…
2026-08-01 22:54:322026-06A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078252-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A078252-002AP1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciprofloxacin in DextroseCIPROFLOXACINProPharma Distribution42c758be-4d44-018a-e063-6294a90ae0412025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078252
application number: ANDA078252
Ciprofloxacin in DextroseCIPROFLOXACINHospira, Inc.cbbbf939-3219-4515-a48e-ca264daa4d072025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078252
application number: ANDA078252
CiprofloxacinCIPROFLOXACINSagent Pharmaceuticalsf406e796-17d9-4465-b8a7-00d966a4ba742024-09-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078252
application number: ANDA078252
CiprofloxacinCIPROFLOXACINSagent Pharmaceuticals7049f870-6741-4a67-8033-398c36126a062022-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078252
application number: ANDA078252

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-3240-092020-05-07C16284748780-19d75b9d0-c913-f424-e053-dadaa90a57ceCIPROFLOXACIN INJECTION, USP For Intravenous Infusion
0781-3240-092020-01-31C16284748780-19d75b9d0-c913-f424-e053-dadaa90a57ceCIPROFLOXACIN INJECTION, USP For Intravenous Infusion

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3240-09ML - Milliliter0781-324026f2bfa5-647f-4847-9bd6-f0d02c4f9eb912013-02-13
0781-3240-48ML - Milliliter0781-324052741a5a-a431-476a-8a24-28b20fbfeeda12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACINACTIVE INGREDIENT5E8K9I0O4UCIPROFLOXACIN INJECTION [SANDOZ INC]12
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN INJECTION [SANDOZ INC]12
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GCIPROFLOXACIN INJECTION [SANDOZ INC]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCIPROFLOXACIN INJECTION [SANDOZ INC]12
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATCIPROFLOXACIN INJECTION [SANDOZ INC]12