FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71205-997
11-digit product format
712050997
Labeler code
71205
Product ID
71205-997_1c1b4148-3301-4ab7-8955-667658b4c133
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076126
Marketing category
ANDA
Marketing start
2009-10-10
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
71205-997-00Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED1002
71205-997-10Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED102
71205-997-14Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED142
71205-997-20Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED202
71205-997-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED302
71205-997-55Ciprofloxacin500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-997CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20220716_a093ca6e-9963-4eea-b60d-6e2f148192ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNa093ca6e-9963-4eea-b60d-6e2f148192ec2
309309ciprofloxacin 500 MG Oral TabletSCDa093ca6e-9963-4eea-b60d-6e2f148192ec2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa093ca6e-9963-4eea-b60d-6e2f148192ec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-997-0071205099700100 TABLET, FILM COATED in 1 BOTTLE (71205-997-00) 2020-03-250000-00-00NoNoCurrent
71205-997-107120509971010 TABLET, FILM COATED in 1 BOTTLE (71205-997-10) 2020-03-250000-00-00NoNoCurrent
71205-997-147120509971414 TABLET, FILM COATED in 1 BOTTLE (71205-997-14) 2020-03-250000-00-00NoNoCurrent
71205-997-207120509972020 TABLET, FILM COATED in 1 BOTTLE (71205-997-20) 2020-03-250000-00-00NoNoCurrent
71205-997-307120509973030 TABLET, FILM COATED in 1 BOTTLE (71205-997-30) 2020-03-250000-00-00NoNoCurrent
71205-997-5571205099755500 TABLET, FILM COATED in 1 BOTTLE (71205-997-55) 2020-03-250000-00-00NoNoCurrent