ciprofloxacin

Product NDC
67046-1528
11-digit product format
670461528
Labeler code
67046
Product ID
67046-1528_2fff6ac3-455d-7df0-e063-6394a90a0672
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA076639
Marketing category
ANDA
Marketing start
2025-03-10
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ciprofloxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197512

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1528-3ciprofloxacin30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1528CIPROFLOXACIN TABLET [COUPLER LLC]1Current NDC, 1 package rows20250311_2fff7a38-2c4e-d343-e063-6294a90aca3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197512ciprofloxacin 750 MG Oral TabletPSN2fff7a38-2c4e-d343-e063-6294a90aca3c1
197512ciprofloxacin 750 MG Oral TabletSCD2fff7a38-2c4e-d343-e063-6294a90aca3c1
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY2fff7a38-2c4e-d343-e063-6294a90aca3c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1528-36704615280330 TABLET in 1 BLISTER PACK (67046-1528-3) 30 tablet2025-03-10NoNoHistorical