FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
61442-223
11-digit product format
614420223
Labeler code
61442
Product ID
61442-223_2d6a2060-1f59-696d-e063-6394a90a2796
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA076126
Marketing category
ANDA
Marketing start
2009-10-10
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
Rxcui197511, 197512, 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
61442-223-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED10016
61442-223-05Ciprofloxacin500 in 1 BOTTLETABLET, FILM COATED50016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-223-01EA - Each61442-22306440a7f-4395-4122-a531-2860a9a0fa6812012-07-24
61442-223-05EA - Each61442-22367bdcd1e-b9a3-47bc-a032-359710d3ad4812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TCIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
TRIACETININACTIVE INGREDIENTXHX3C3X673CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2CIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TCIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
TRIACETININACTIVE INGREDIENTXHX3C3X673CIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-223CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]16Current NDC, Legacy NDC, 2 package rows20250207_37527eca-115e-4582-88cd-bba851ac6069.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN99918613-7936-47dd-8565-9cd6c0cc22e3106
309309ciprofloxacin 500 MG Oral TabletSCD99918613-7936-47dd-8565-9cd6c0cc22e3106
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY99918613-7936-47dd-8565-9cd6c0cc22e3106
309309ciprofloxacin 500 MG Oral TabletPSN74e2dd24-5c6e-4dde-a2ab-f2d2e61734d831
309309ciprofloxacin 500 MG Oral TabletSCD74e2dd24-5c6e-4dde-a2ab-f2d2e61734d831
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY74e2dd24-5c6e-4dde-a2ab-f2d2e61734d831
309309ciprofloxacin 500 MG Oral TabletPSNcfda82e4-8660-447e-a881-b87165a31e9a30
309309ciprofloxacin 500 MG Oral TabletSCDcfda82e4-8660-447e-a881-b87165a31e9a30
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYcfda82e4-8660-447e-a881-b87165a31e9a30
197511ciprofloxacin 250 MG Oral TabletPSN37527eca-115e-4582-88cd-bba851ac606916
309309ciprofloxacin 500 MG Oral TabletPSNbb2edaca-6cf2-4100-83f5-8ce142f68e5916
309309ciprofloxacin 500 MG Oral TabletPSN37527eca-115e-4582-88cd-bba851ac606916
197512ciprofloxacin 750 MG Oral TabletPSN37527eca-115e-4582-88cd-bba851ac606916
197511ciprofloxacin 250 MG Oral TabletSCD37527eca-115e-4582-88cd-bba851ac606916
309309ciprofloxacin 500 MG Oral TabletSCDbb2edaca-6cf2-4100-83f5-8ce142f68e5916
309309ciprofloxacin 500 MG Oral TabletSCD37527eca-115e-4582-88cd-bba851ac606916
197512ciprofloxacin 750 MG Oral TabletSCD37527eca-115e-4582-88cd-bba851ac606916
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYbb2edaca-6cf2-4100-83f5-8ce142f68e5916
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY37527eca-115e-4582-88cd-bba851ac606916
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY37527eca-115e-4582-88cd-bba851ac606916
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY37527eca-115e-4582-88cd-bba851ac606916
309309ciprofloxacin 500 MG Oral TabletPSNd17b0e87-b555-4dfb-e053-2a95a90aa5ef9
309309ciprofloxacin 500 MG Oral TabletSCDd17b0e87-b555-4dfb-e053-2a95a90aa5ef9
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd17b0e87-b555-4dfb-e053-2a95a90aa5ef9
309309ciprofloxacin 500 MG Oral TabletPSN8eef4f14-e7ef-41be-be57-7993b333e8a98
309309ciprofloxacin 500 MG Oral TabletSCD8eef4f14-e7ef-41be-be57-7993b333e8a98
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY8eef4f14-e7ef-41be-be57-7993b333e8a98
197511ciprofloxacin 250 MG Oral TabletPSNb283d662-9be1-49c7-be03-cb21055314c16
309309ciprofloxacin 500 MG Oral TabletPSNb283d662-9be1-49c7-be03-cb21055314c16
197511ciprofloxacin 250 MG Oral TabletSCDb283d662-9be1-49c7-be03-cb21055314c16
309309ciprofloxacin 500 MG Oral TabletSCDb283d662-9be1-49c7-be03-cb21055314c16
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYb283d662-9be1-49c7-be03-cb21055314c16
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYb283d662-9be1-49c7-be03-cb21055314c16
309309ciprofloxacin 500 MG Oral TabletPSNa093ca6e-9963-4eea-b60d-6e2f148192ec2
309309ciprofloxacin 500 MG Oral TabletPSNde0b9579-fb85-e1ce-e053-2a95a90aeecb2
309309ciprofloxacin 500 MG Oral TabletSCDa093ca6e-9963-4eea-b60d-6e2f148192ec2
309309ciprofloxacin 500 MG Oral TabletSCDde0b9579-fb85-e1ce-e053-2a95a90aeecb2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa093ca6e-9963-4eea-b60d-6e2f148192ec2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYde0b9579-fb85-e1ce-e053-2a95a90aeecb2
309309ciprofloxacin 500 MG Oral TabletPSNebf6f608-01bc-4867-a747-833120b87dd91
309309ciprofloxacin 500 MG Oral TabletPSNe1afd2dd-6f01-4798-a9d8-0125c38f1e421
309309ciprofloxacin 500 MG Oral TabletPSNdf24efa3-c9a0-4f40-92ce-cc71c708931b1
309309ciprofloxacin 500 MG Oral TabletSCDdf24efa3-c9a0-4f40-92ce-cc71c708931b1
309309ciprofloxacin 500 MG Oral TabletSCDe1afd2dd-6f01-4798-a9d8-0125c38f1e421
309309ciprofloxacin 500 MG Oral TabletSCDebf6f608-01bc-4867-a747-833120b87dd91
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYe1afd2dd-6f01-4798-a9d8-0125c38f1e421
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYebf6f608-01bc-4867-a747-833120b87dd91
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYdf24efa3-c9a0-4f40-92ce-cc71c708931b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61442-223-0161442022301100 TABLET, FILM COATED in 1 BOTTLE (61442-223-01) 2009-10-100000-00-00NoNoCurrent
61442-223-0561442022305500 TABLET, FILM COATED in 1 BOTTLE (61442-223-05) 2009-10-100000-00-00NoNoCurrent