FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
76420-214
11-digit product format
764200214
Labeler code
76420
Product ID
76420-214_d9b54ffb-864f-1ca8-e053-2995a90a5144
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA076558
Marketing category
ANDA
Marketing start
2004-06-09
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
76420-214-06Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED61
76420-214-10Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED101
76420-214-14Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED141
76420-214-20Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED201
76420-214-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-214-06EA - Each76420-214439fc24e-a4c7-43b5-aad9-a76558b5603c12022-04-06
76420-214-10EA - Each76420-2145ba9e46d-dfa9-4d22-a34a-287a4cfe0ec012022-04-06
76420-214-14EA - Each76420-2141ef418b0-f214-461c-8584-b04a5b3a2bc312022-04-06
76420-214-20EA - Each76420-21486fda8db-1aea-43db-8d10-d951423e8e2c12022-04-06
76420-214-30EA - Each76420-2143ce0ac1a-e9f8-494c-89cd-4ebe74d36d0412022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-214CIPROFLOXACIN TABLET, FILM COATED [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 5 package rows20220309_1bb1d26e-fad0-4338-8948-3f095d5817a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN1bb1d26e-fad0-4338-8948-3f095d5817a61
197511ciprofloxacin 250 MG Oral TabletSCD1bb1d26e-fad0-4338-8948-3f095d5817a61
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY1bb1d26e-fad0-4338-8948-3f095d5817a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-214-06764200214066 TABLET, FILM COATED in 1 BOTTLE (76420-214-06) 2022-03-080000-00-00NoNoCurrent
76420-214-107642002141010 TABLET, FILM COATED in 1 BOTTLE (76420-214-10) 2022-03-080000-00-00NoNoCurrent
76420-214-147642002141414 TABLET, FILM COATED in 1 BOTTLE (76420-214-14) 2022-03-080000-00-00NoNoCurrent
76420-214-207642002142020 TABLET, FILM COATED in 1 BOTTLE (76420-214-20) 2022-03-080000-00-00NoNoCurrent
76420-214-307642002143030 TABLET, FILM COATED in 1 BOTTLE (76420-214-30) 2022-03-080000-00-00NoNoCurrent