FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
69117-0008
11-digit product format
691170008
Labeler code
69117
Product ID
69117-0008_47236eca-557e-1b27-e063-6394a90acd14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Yiling Pharmaceutical, Inc.
Application
ANDA208921
Marketing category
ANDA
Marketing start
2019-07-13
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
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, 309309

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
69117-0008-1Ciprofloxacin100 in 1 BOTTLETABLET, COATED10021
69117-0008-2Ciprofloxacin500 in 1 BOTTLETABLET, COATED50021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69117-0008-1EA - Each69117-0008c6232564-4cbf-45ce-b755-1910b5e9e5e512019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-0008CIPROFLOXACIN (CIPROFLOXACIN TABLETS) TABLET, COATED [YILING PHARMACEUTICAL, INC.]20Current NDC, Legacy NDC, 2 package rows20250101_6fd3da0b-7428-ac8f-e053-2a91aa0aed9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN6fd3da0b-7428-ac8f-e053-2a91aa0aed9f21
309309ciprofloxacin 500 MG Oral TabletPSN6fd3da0b-7428-ac8f-e053-2a91aa0aed9f21
197511ciprofloxacin 250 MG Oral TabletSCD6fd3da0b-7428-ac8f-e053-2a91aa0aed9f21
309309ciprofloxacin 500 MG Oral TabletSCD6fd3da0b-7428-ac8f-e053-2a91aa0aed9f21
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY6fd3da0b-7428-ac8f-e053-2a91aa0aed9f21
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY6fd3da0b-7428-ac8f-e053-2a91aa0aed9f21
197511ciprofloxacin 250 MG Oral TabletPSN8d6ec3ee-2205-4d78-bc48-d39f371797c18
197511ciprofloxacin 250 MG Oral TabletSCD8d6ec3ee-2205-4d78-bc48-d39f371797c18
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY8d6ec3ee-2205-4d78-bc48-d39f371797c18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69117-0008-169117000801100 TABLET, COATED in 1 BOTTLE (69117-0008-1) 2019-07-130000-00-00NoNoCurrent
69117-0008-269117000802500 TABLET, COATED in 1 BOTTLE (69117-0008-2) 2019-07-130000-00-00NoNoCurrent