FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71205-749
11-digit product format
712050749
Labeler code
71205
Product ID
71205-749_6b5fe0aa-c74f-42f3-a84a-1cb16009aa80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208921
Marketing category
ANDA
Marketing start
2020-08-12
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
71205-749-05Ciprofloxacin5 in 1 BOTTLETABLET, COATED51
71205-749-06Ciprofloxacin6 in 1 BOTTLETABLET, COATED61
71205-749-10Ciprofloxacin10 in 1 BOTTLETABLET, COATED101
71205-749-14Ciprofloxacin14 in 1 BOTTLETABLET, COATED141
71205-749-20Ciprofloxacin20 in 1 BOTTLETABLET, COATED201
71205-749-28Ciprofloxacin28 in 1 BOTTLETABLET, COATED281
71205-749-30Ciprofloxacin30 in 1 BOTTLETABLET, COATED301
71205-749-60Ciprofloxacin60 in 1 BOTTLETABLET, COATED601
71205-749-90Ciprofloxacin90 in 1 BOTTLETABLET, COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-749-20EA - Each71205-7494ee23e35-28e3-49ab-a61d-3555cff5768612023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-749CIPROFLOXACIN TABLET, COATED [PROFICIENT RX LP]1Current NDC, 9 package rows20230204_6b5fe0aa-c74f-42f3-a84a-1cb16009aa80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN6b5fe0aa-c74f-42f3-a84a-1cb16009aa801
197511ciprofloxacin 250 MG Oral TabletSCD6b5fe0aa-c74f-42f3-a84a-1cb16009aa801
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY6b5fe0aa-c74f-42f3-a84a-1cb16009aa801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-749-05712050749055 TABLET, COATED in 1 BOTTLE (71205-749-05) 2023-01-26NoNoCurrent
71205-749-06712050749066 TABLET, COATED in 1 BOTTLE (71205-749-06) 2023-01-26NoNoCurrent
71205-749-107120507491010 TABLET, COATED in 1 BOTTLE (71205-749-10) 2023-01-26NoNoCurrent
71205-749-147120507491414 TABLET, COATED in 1 BOTTLE (71205-749-14) 2023-01-26NoNoCurrent
71205-749-207120507492020 TABLET, COATED in 1 BOTTLE (71205-749-20) 2023-01-26NoNoCurrent
71205-749-287120507492828 TABLET, COATED in 1 BOTTLE (71205-749-28) 2023-01-26NoNoCurrent
71205-749-307120507493030 TABLET, COATED in 1 BOTTLE (71205-749-30) 2023-01-26NoNoCurrent
71205-749-607120507496060 TABLET, COATED in 1 BOTTLE (71205-749-60) 2023-01-26NoNoCurrent
71205-749-907120507499090 TABLET, COATED in 1 BOTTLE (71205-749-90) 2023-01-26NoNoCurrent