FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
68788-8136
11-digit product format
687888136
Labeler code
68788
Product ID
68788-8136_e6e1419a-65f6-42a7-a4f9-67a2fdf7aa53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077859
Marketing category
ANDA
Marketing start
2022-02-03
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 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 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
68788-8136-0Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED64
68788-8136-1Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED144
68788-8136-2Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED204
68788-8136-3Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED304
68788-8136-8Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8136-0EA - Each68788-813642006914-d763-44f6-9cc7-221fe96f077f12022-03-09
68788-8136-1EA - Each68788-81369404edf8-9cb9-45ad-ac5e-00f2343a24ba12022-03-09
68788-8136-2EA - Each68788-8136758a01d4-289c-4756-baa4-65c59e5c90a412022-03-09
68788-8136-3EA - Each68788-81369eaf7c9f-ceba-4338-9915-0f807110acca12022-03-09
68788-8136-8EA - Each68788-81364de020b6-0bb6-4d0e-9786-e599db95b31d12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8136CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 5 package rows20250303_1cb05412-372e-4b49-92e1-532caa05f38f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN1cb05412-372e-4b49-92e1-532caa05f38f4
309309ciprofloxacin 500 MG Oral TabletSCD1cb05412-372e-4b49-92e1-532caa05f38f4
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY1cb05412-372e-4b49-92e1-532caa05f38f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8136-0687888136006 TABLET, FILM COATED in 1 BOTTLE (68788-8136-0) 2022-02-030000-00-00NoNoCurrent
68788-8136-16878881360114 TABLET, FILM COATED in 1 BOTTLE (68788-8136-1) 2022-02-030000-00-00NoNoCurrent
68788-8136-26878881360220 TABLET, FILM COATED in 1 BOTTLE (68788-8136-2) 2022-02-030000-00-00NoNoCurrent
68788-8136-36878881360330 TABLET, FILM COATED in 1 BOTTLE (68788-8136-3) 2022-02-030000-00-00NoNoCurrent
68788-8136-86878881360810 TABLET, FILM COATED in 1 BOTTLE (68788-8136-8) 2022-02-030000-00-00NoNoCurrent