FDA.reportPublic FDA data

Ciprofloxacin Hydrochloride

Product NDC
50090-7843
11-digit product format
500907843
Labeler code
50090
Product ID
50090-7843_56da4ad6-dcd2-4df7-b174-e78c8e0127b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076593
Marketing category
ANDA
Marketing start
2024-05-23
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 Hydrochloride
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
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
50090-7843-0Ciprofloxacin Hydrochloride20 in 1 BOTTLETABLET, FILM COATED201
50090-7843-1Ciprofloxacin Hydrochloride14 in 1 BOTTLETABLET, FILM COATED141
50090-7843-3Ciprofloxacin Hydrochloride6 in 1 BOTTLETABLET, FILM COATED61
50090-7843-4Ciprofloxacin Hydrochloride28 in 1 BOTTLETABLET, FILM COATED281
50090-7843-5Ciprofloxacin Hydrochloride10 in 1 BOTTLETABLET, FILM COATED101
50090-7843-7Ciprofloxacin Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
50090-7843-8Ciprofloxacin Hydrochloride1 in 1 BOTTLETABLET, FILM COATED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7843-0EA - Each50090-784344aab293-7067-4949-aa5c-cdf2fc375e1612026-02-05
50090-7843-1EA - Each50090-7843b80488f2-caa9-46ea-a6ad-9f27b63b785812026-02-05
50090-7843-3EA - Each50090-7843a45c63d0-06d0-4d82-a2d1-a8f376c156a812026-02-05
50090-7843-4EA - Each50090-78434c6beb0a-149d-4ed3-b8b3-ce7d423cf25212026-02-05
50090-7843-5EA - Each50090-7843db25c3e3-35af-4421-8359-2fbc39cb932b12026-02-05
50090-7843-7EA - Each50090-78439b1123f4-cb24-4d75-8b4e-f67187ecdeb912026-02-05
50090-7843-8EA - Each50090-784304e33e3d-8240-4627-99fa-724e00d7a84312026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN6d029ad2-a1e8-4c11-a5eb-e2257c6a0ddb1
309309ciprofloxacin 500 MG Oral TabletSCD6d029ad2-a1e8-4c11-a5eb-e2257c6a0ddb1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY6d029ad2-a1e8-4c11-a5eb-e2257c6a0ddb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7843-05009078430020 TABLET, FILM COATED in 1 BOTTLE (50090-7843-0) 2025-12-30NoNoHistorical
50090-7843-15009078430114 TABLET, FILM COATED in 1 BOTTLE (50090-7843-1) 2025-12-30NoNoHistorical
50090-7843-3500907843036 TABLET, FILM COATED in 1 BOTTLE (50090-7843-3) 2025-12-30NoNoHistorical
50090-7843-45009078430428 TABLET, FILM COATED in 1 BOTTLE (50090-7843-4) 2025-12-30NoNoHistorical
50090-7843-55009078430510 TABLET, FILM COATED in 1 BOTTLE (50090-7843-5) 2025-12-30NoNoHistorical
50090-7843-75009078430730 TABLET, FILM COATED in 1 BOTTLE (50090-7843-7) 2025-12-30NoNoHistorical
50090-7843-8500907843081 TABLET, FILM COATED in 1 BOTTLE (50090-7843-8) 2025-12-30NoNoHistorical