CIPROFLOXACIN

Product NDC
36000-297
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.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct36000-297DDiscontinued by firm2026-07-31
excluded packagepackage36000-29736000-297-24DDiscontinued by firm2026-07-31

Orange Book products#

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

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