FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
70934-965
11-digit product format
709340965
Labeler code
70934
Product ID
70934-965_e10891a7-9e65-ca14-e053-2995a90afa2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA076126
Marketing category
ANDA
Marketing start
2022-05-02
Marketing end
2026-08-31
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [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
70934-965-06Ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET, FILM COATED62
70934-965-14Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED142
70934-965-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
70934-965-30Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
70934-965-60Ciprofloxacin60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-965CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 5 package rows20230112_de0b9579-fb85-e1ce-e053-2a95a90aeecb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNde0b9579-fb85-e1ce-e053-2a95a90aeecb2
309309ciprofloxacin 500 MG Oral TabletSCDde0b9579-fb85-e1ce-e053-2a95a90aeecb2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYde0b9579-fb85-e1ce-e053-2a95a90aeecb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-965-06709340965066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-06) 2022-05-022026-08-31NoNoCurrent
70934-965-147093409651414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-14) 2022-05-022026-08-31NoNoCurrent
70934-965-207093409652020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-20) 2022-05-022026-08-31NoNoCurrent
70934-965-307093409653030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-30) 2022-05-162026-08-31NoNoCurrent
70934-965-607093409656060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-60) 2022-06-092026-08-31NoNoCurrent