Ciprofloxacin

Product NDC
0904-7083
11-digit product format
009047083
Labeler code
0904
Product ID
0904-7083_221a02bc-9da3-4a75-b42b-b34b6ea11013
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA076558
Marketing category
ANDA
Marketing start
2004-06-09
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7083-61EA - Each0904-708369c80a3d-90ba-4857-b912-718205dc177a12021-05-05
0904-7083-95EA - Each0904-7083a4015243-7171-4ffb-94b1-ecd19ce727d812021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7083CIPROFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]6Legacy NDC20250529_62cb8a94-05a3-48e4-9b51-4ff0e2a72f10.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7083-6100904708361100 BLISTER PACK in 1 CARTON (0904-7083-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2004-06-090000-00-00NoNoCurrent
0904-7083-950090470839520 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0904-7083-95) 2004-06-090000-00-00NoNoCurrent