FDA.reportPublic FDA data

ciprofloxacin

Product NDC
54348-662
11-digit product format
543480662
Labeler code
54348
Product ID
54348-662_ea938405-8d24-fa08-e053-2995a90af8dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIPROFLOXACIN
Dosage form
TABLET
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA076639
Marketing category
ANDA
Marketing start
2019-07-10
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [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 HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197511

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
54348-662-06ciprofloxacin6 in 1 BOTTLETABLET63
54348-662-06ciprofloxacin1 in 1 BOXTABLET13
54348-662-14ciprofloxacin1 in 1 BOXTABLET13
54348-662-14ciprofloxacin14 in 1 BOTTLETABLET143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-662CIPROFLOXACIN TABLET [PHARMPAK, INC.]3Current NDC, Legacy NDC, 4 package rows20221011_e2902d14-16bb-46a9-a45a-4f1f9b0ecf4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNe2902d14-16bb-46a9-a45a-4f1f9b0ecf4a3
197511ciprofloxacin 250 MG Oral TabletSCDe2902d14-16bb-46a9-a45a-4f1f9b0ecf4a3
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYe2902d14-16bb-46a9-a45a-4f1f9b0ecf4a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-662-06543480662061 BOTTLE in 1 BOX (54348-662-06) / 6 TABLET in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
54348-662-14543480662141 BOTTLE in 1 BOX (54348-662-14) / 14 TABLET in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent