ciprofloxacin

Product NDC
54348-663
11-digit product format
543480663
Labeler code
54348
Product ID
54348-663_ea938ef9-a316-2003-e053-2a95a90aa829
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
500 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 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
54348-663-01ciprofloxacin1 in 1 BOXTABLET12
54348-663-01ciprofloxacin1 in 1 BOTTLETABLET12
54348-663-06ciprofloxacin1 in 1 BOXTABLET12
54348-663-06ciprofloxacin6 in 1 BOTTLETABLET62
54348-663-14ciprofloxacin1 in 1 BOXTABLET12
54348-663-14ciprofloxacin14 in 1 BOTTLETABLET142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-663CIPROFLOXACIN TABLET [PHARMPAK, INC.]2Current NDC, Legacy NDC, 6 package rows20221011_6a70db6c-ae68-49e5-8a4a-b5cd1d4840bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN6a70db6c-ae68-49e5-8a4a-b5cd1d4840bd2
309309ciprofloxacin 500 MG Oral TabletSCD6a70db6c-ae68-49e5-8a4a-b5cd1d4840bd2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY6a70db6c-ae68-49e5-8a4a-b5cd1d4840bd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-663-01543480663011 BOTTLE in 1 BOX (54348-663-01) / 1 TABLET in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
54348-663-06543480663061 BOTTLE in 1 BOX (54348-663-06) / 6 TABLET in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
54348-663-14543480663141 BOTTLE in 1 BOX (54348-663-14) / 14 TABLET in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent