FDA.reportPublic FDA data

CIPROFLOXACIN

Product NDC
36000-297
Requested package NDC
36000-297-24
11-digit product format
360000297
Labeler code
36000
Product ID
36000-297_bbf4e635-5611-4ceb-9d32-620d204a1c92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIPROFLOXACIN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA078024
Marketing category
ANDA
Marketing start
2008-08-04
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36000-29736000-297-24DDiscontinued 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
A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN200MG/100MLINJECTABLE / INJECTION2008-03-18
A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN400MG/200MLINJECTABLE / INJECTION2008-03-18

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 22:54:322026-06A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION2008-03-18a50c72e98297…
2026-08-01 22:54:322026-06A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTION2008-03-18a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36000-297-24ML - Milliliter36000-297fc55a7e2-f843-4a7b-b10f-5d1c408f9bde12020-01-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36000-297-2436000029724100 mL in 1 BAG (36000-297-24) 100 ml2019-12-230000-00-00NoNoCurrent