FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
72789-108
11-digit product format
727890108
Labeler code
72789
Product ID
72789-108_4d622f0c-9f42-a920-e063-6394a90a0f73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076558
Marketing category
ANDA
Marketing start
2004-06-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin
Listing expiration
2027-12-31

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
72789-108-02Ciprofloxacin2 in 1 BOTTLE, PLASTICTABLET, FILM COATED234
72789-108-10Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1034
72789-108-14Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1434
72789-108-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2034
72789-108-28Ciprofloxacin28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2834
72789-108-30Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-108-02EA - Each72789-1080144d16d-3bac-4522-863d-78e740115d9212022-05-04
72789-108-06EA - Each72789-1080a0eda56-0863-4874-9781-050438f0cc9d12022-05-04
72789-108-10EA - Each72789-108e9788987-ce6c-44ab-9889-3ac0ec4c3f1312022-01-06
72789-108-14EA - Each72789-1085bc9aeca-1c62-4932-bc3a-eb9a22c1c15f12021-11-09
72789-108-20EA - Each72789-108b5555f2a-f89b-41a0-befd-9e843d24717d12021-02-05
72789-108-28EA - Each72789-108a6e83329-6d1a-4308-9d7e-dee5a1f43ed312022-06-06
72789-108-30EA - Each72789-108f4e48db7-f24a-4043-94a3-a4c7a2ed439e12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-108CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]33Current NDC, Legacy NDC, 6 package rows20250207_3b9b15f7-354b-4049-982b-f6f31751a885.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN3b9b15f7-354b-4049-982b-f6f31751a88534
309309ciprofloxacin 500 MG Oral TabletSCD3b9b15f7-354b-4049-982b-f6f31751a88534
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY3b9b15f7-354b-4049-982b-f6f31751a88534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-108-02727890108022 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-108-02) 2022-04-050000-00-00NoNoCurrent
72789-108-06727890108066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-108-06) 2022-04-050000-00-00NoNoCurrent
72789-108-107278901081010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-108-10) 2021-12-090000-00-00NoNoCurrent
72789-108-147278901081414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-108-14) 2021-07-210000-00-00NoNoCurrent
72789-108-207278901082020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-108-20) 2020-12-300000-00-00NoNoCurrent
72789-108-287278901082828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-108-28) 2022-05-050000-00-00NoNoCurrent
72789-108-307278901083030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-108-30) 2020-12-090000-00-00NoNoCurrent