FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
76420-045
11-digit product format
764200045
Labeler code
76420
Product ID
76420-045_50958031-77c0-2b97-e063-6394a90a2c43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA077859
Marketing category
ANDA
Marketing start
2007-04-26
Marketing end
2026-10-31
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin

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
76420-045-06Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED62
76420-045-10Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED102
76420-045-14Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED142
76420-045-20Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED202
76420-045-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-045-06EA - Each76420-0453818dac6-eaab-4245-ac47-86be3c103d6b12022-05-04
76420-045-14EA - Each76420-045e65241a0-d6c9-44d5-b9fa-34756aec0c8e12022-05-04
76420-045-20EA - Each76420-045559d737d-fcf2-47e4-bc67-ddd53f383b4d12022-05-04
76420-045-30EA - Each76420-0455c520c55-1957-4b9c-afc4-d75a058cde8112022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-045CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 5 package rows20200905_ae77a5c0-a2ae-770c-e053-2a95a90a6a96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNae77a5c0-a2ae-770c-e053-2a95a90a6a962
309309ciprofloxacin 500 MG Oral TabletSCDae77a5c0-a2ae-770c-e053-2a95a90a6a962
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYae77a5c0-a2ae-770c-e053-2a95a90a6a962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-045-06764200045066 TABLET, FILM COATED in 1 BOTTLE (76420-045-06) 2020-09-042026-10-31NoNoCurrent
76420-045-107642000451010 TABLET, FILM COATED in 1 BOTTLE (76420-045-10) 2020-09-042026-10-31NoNoCurrent
76420-045-147642000451414 TABLET, FILM COATED in 1 BOTTLE (76420-045-14) 2020-09-042026-10-31NoNoCurrent
76420-045-207642000452020 TABLET, FILM COATED in 1 BOTTLE (76420-045-20) 2020-09-042026-10-31NoNoCurrent
76420-045-307642000453030 TABLET, FILM COATED in 1 BOTTLE (76420-045-30) 2020-09-042026-10-31NoNoCurrent