FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71205-649
11-digit product format
712050649
Labeler code
71205
Product ID
71205-649_00f44d29-72b5-47a6-a26a-eb1f1c430917
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077859
Marketing category
ANDA
Marketing start
2007-04-26
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
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
71205-649-06Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED64
71205-649-07Ciprofloxacin7 in 1 BOTTLETABLET, FILM COATED74
71205-649-10Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED104
71205-649-14Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED144
71205-649-20Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED204
71205-649-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED304
71205-649-60Ciprofloxacin60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-649-06EA - Each71205-64953dc94e9-b3ed-4ea8-bbec-2f485c5abb6412022-06-06
71205-649-07EA - Each71205-649a974c0ed-491a-46b3-a60a-a784c0ed706412024-08-12
71205-649-10EA - Each71205-6494aba3da3-55d1-4807-bce8-4303b5b08eb212022-08-04
71205-649-14EA - Each71205-6494d0e71b2-6432-461b-977d-a2412e8d43f212022-06-06
71205-649-20EA - Each71205-649ed10c6f5-335c-4aa3-817c-6418a5dd4d8712023-03-13
71205-649-30EA - Each71205-649a9252b9a-ed7f-469f-a817-052e6fcb42fb12023-08-08
71205-649-60EA - Each71205-6495eff1207-7525-4a9a-aa37-a3c8f628959d12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-649CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 7 package rows20240629_ec337816-4f48-4d04-b91d-60f9f5f634da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNec337816-4f48-4d04-b91d-60f9f5f634da4
309309ciprofloxacin 500 MG Oral TabletSCDec337816-4f48-4d04-b91d-60f9f5f634da4
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYec337816-4f48-4d04-b91d-60f9f5f634da4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-649-06712050649066 TABLET, FILM COATED in 1 BOTTLE (71205-649-06) 2022-03-280000-00-00NoNoCurrent
71205-649-07712050649077 TABLET, FILM COATED in 1 BOTTLE (71205-649-07) 2024-06-26NoNoCurrent
71205-649-107120506491010 TABLET, FILM COATED in 1 BOTTLE (71205-649-10) 2022-03-280000-00-00NoNoCurrent
71205-649-147120506491414 TABLET, FILM COATED in 1 BOTTLE (71205-649-14) 2022-03-280000-00-00NoNoCurrent
71205-649-207120506492020 TABLET, FILM COATED in 1 BOTTLE (71205-649-20) 2022-03-280000-00-00NoNoCurrent
71205-649-217120506492121 TABLET, FILM COATED in 1 BOTTLE (71205-649-21) 2022-03-280000-00-00NoNoCurrent
71205-649-307120506493030 TABLET, FILM COATED in 1 BOTTLE (71205-649-30) 2022-03-280000-00-00NoNoCurrent
71205-649-607120506496060 TABLET, FILM COATED in 1 BOTTLE (71205-649-60) 2022-03-280000-00-00NoNoCurrent
71205-649-907120506499090 TABLET, FILM COATED in 1 BOTTLE (71205-649-90) 2022-03-280000-00-00NoNoCurrent