FDA.reportPublic FDA data

ciprofloxacin

Product NDC
70934-045
11-digit product format
709340045
Labeler code
70934
Product ID
70934-045_9cb3ea8d-9ff3-4f47-e053-2995a90a2e57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA076639
Marketing category
ANDA
Marketing start
2017-11-21
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
70934-045-062022-01-28C16284748780-1d6a99b39-a02c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
70934-045-102022-01-28C16284748780-1d6a99b39-a02c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
70934-045-142022-01-28C16284748780-1d6a99b39-a02c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
70934-045-202022-01-28C16284748780-1d6a99b39-a02c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
70934-045-302022-01-28C16284748780-1d6a99b39-a02c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
70934-045-602022-01-28C16284748780-1d6a99b39-a02c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-045-06ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET67
70934-045-10ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET107
70934-045-14ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET147
70934-045-20ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET207
70934-045-30ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET307
70934-045-60ciprofloxacin60 in 1 BOTTLE, PLASTICTABLET607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-045-06EA - Each70934-045cf147620-5154-476d-aa1e-faf9fb7edd8212018-02-20
70934-045-10EA - Each70934-04579fe75d9-c60c-47ed-b719-1bd3ca33b09512018-02-20
70934-045-14EA - Each70934-045bf01f936-5c9b-4393-8a5f-31f83023ecc212018-11-06
70934-045-20EA - Each70934-0451e27ea3e-8556-4ce5-aefa-f0c24a98cde212018-05-09
70934-045-30EA - Each70934-04521bd3ed2-19c8-4287-96ac-43c89cdce15d12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-045CIPROFLOXACIN TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]7Legacy NDC, 6 package rows20200122_5fd60635-4b68-15e3-e053-2991aa0ab23a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN5fd60635-4b68-15e3-e053-2991aa0ab23a7
309309ciprofloxacin 500 MG Oral TabletSCD5fd60635-4b68-15e3-e053-2991aa0ab23a7
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY5fd60635-4b68-15e3-e053-2991aa0ab23a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-045-06709340045066 TABLET in 1 BOTTLE, PLASTIC (70934-045-06) 6 tablet2017-11-210000-00-00NoNoCurrent
70934-045-107093400451010 TABLET in 1 BOTTLE, PLASTIC (70934-045-10) 10 tablet2017-11-280000-00-00NoNoCurrent
70934-045-147093400451414 TABLET in 1 BOTTLE, PLASTIC (70934-045-14) 14 tablet2018-09-050000-00-00NoNoCurrent
70934-045-207093400452020 TABLET in 1 BOTTLE, PLASTIC (70934-045-20) 20 tablet2018-01-250000-00-00NoNoCurrent
70934-045-307093400453030 TABLET in 1 BOTTLE, PLASTIC (70934-045-30) 30 tablet2020-01-090000-00-00NoNoCurrent
70934-045-607093400456060 TABLET in 1 BOTTLE, PLASTIC (70934-045-60) 60 tablet2018-11-130000-00-00NoNoCurrent