FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
68788-8200
11-digit product format
687888200
Labeler code
68788
Product ID
68788-8200_95a94f27-0676-4285-b5ab-e391ff9e4204
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208921
Marketing category
ANDA
Marketing start
2022-05-24
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8200-1Ciprofloxacin10 in 1 BOTTLETABLET, COATED105
68788-8200-2Ciprofloxacin20 in 1 BOTTLETABLET, COATED205
68788-8200-3Ciprofloxacin30 in 1 BOTTLETABLET, COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8200-1EA - Each68788-82000b8f76ab-6517-48dd-a6b0-cc656d18021112022-07-06
68788-8200-2EA - Each68788-8200dc48cbd8-116e-4707-8968-70199a4d9e1e12022-07-06
68788-8200-3EA - Each68788-8200357b420a-0167-4d86-bd19-bc48f3cc3cbc12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8200CIPROFLOXACIN TABLET, COATED [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20250303_18414c5a-8153-44f7-b27a-90c290af0a23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN18414c5a-8153-44f7-b27a-90c290af0a235
197511ciprofloxacin 250 MG Oral TabletSCD18414c5a-8153-44f7-b27a-90c290af0a235
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY18414c5a-8153-44f7-b27a-90c290af0a235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8200-16878882000110 TABLET, COATED in 1 BOTTLE (68788-8200-1) 2022-05-240000-00-00NoNoCurrent
68788-8200-26878882000220 TABLET, COATED in 1 BOTTLE (68788-8200-2) 2022-05-240000-00-00NoNoCurrent
68788-8200-36878882000330 TABLET, COATED in 1 BOTTLE (68788-8200-3) 2022-05-240000-00-00NoNoCurrent