FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
70518-2837
11-digit product format
705182837
Labeler code
70518
Product ID
70518-2837_4ab6c45a-7fe1-1d11-e063-6394a90a7bbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076558
Marketing category
ANDA
Marketing start
2020-08-18
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 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 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2837-02022-02-07C16284748780-1d6a99b39-c7f8-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use. Initial U.S. Approval: 1987
70518-2837-12022-02-07C16284748780-1d6a99b39-c7f8-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use. Initial U.S. Approval: 1987
70518-2837-02022-01-28C16284748780-1d6a99b39-c7f8-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use. Initial U.S. Approval: 1987
70518-2837-12022-01-28C16284748780-1d6a99b39-c7f8-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use. Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2837-0Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3010
70518-2837-1Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1010
70518-2837-2Ciprofloxacin30 in 1 BLISTER PACKTABLET, FILM COATED3010
70518-2837-3Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2010
70518-2837-4Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2837CIPROFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 5 package rows20250406_c08b37c3-5f01-47ed-9508-02813bbd008b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNc08b37c3-5f01-47ed-9508-02813bbd008b10
197511ciprofloxacin 250 MG Oral TabletSCDc08b37c3-5f01-47ed-9508-02813bbd008b10
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYc08b37c3-5f01-47ed-9508-02813bbd008b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2837-07051828370030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2837-0) 2020-08-180000-00-00NoNoCurrent
70518-2837-17051828370110 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2837-1) 2020-08-190000-00-00NoNoCurrent
70518-2837-27051828370230 TABLET, FILM COATED in 1 BLISTER PACK (70518-2837-2) 2020-10-200000-00-00NoNoCurrent
70518-2837-37051828370320 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2837-3) 2021-01-150000-00-00NoNoCurrent
70518-2837-47051828370414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2837-4) 2023-02-05NoNoHistorical