FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
0615-8630
11-digit product format
006158630
Labeler code
0615
Product ID
0615-8630_c75d65dc-e756-4444-bb23-a92fbba7cb1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA077859
Marketing category
ANDA
Marketing start
2025-03-27
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui309309

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8630-10Ciprofloxacin10 in 1 BLISTER PACKTABLET, FILM COATED102
0615-8630-14Ciprofloxacin14 in 1 BLISTER PACKTABLET, FILM COATED142
0615-8630-20Ciprofloxacin20 in 1 BLISTER PACKTABLET, FILM COATED202

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN26e2d370-f59c-40ae-9c1e-7f8bf1f9fde42
309309ciprofloxacin 500 MG Oral TabletSCD26e2d370-f59c-40ae-9c1e-7f8bf1f9fde42
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY26e2d370-f59c-40ae-9c1e-7f8bf1f9fde42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8630-100061586301010 TABLET, FILM COATED in 1 BLISTER PACK (0615-8630-10) 2026-04-13NoNoHistorical
0615-8630-140061586301414 TABLET, FILM COATED in 1 BLISTER PACK (0615-8630-14) 2026-04-13NoNoHistorical
0615-8630-200061586302020 TABLET, FILM COATED in 1 BLISTER PACK (0615-8630-20) 2026-04-13NoNoHistorical