Ciprofloxacin

Product NDC
63629-3868
11-digit product format
636293868
Labeler code
63629
Product ID
63629-3868_8dabad3c-3808-45cc-a58d-127e3a3d6d6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076558
Marketing category
ANDA
Marketing start
2004-06-09
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
750 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 HYDROCHLORIDE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197512

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
63629-3868-1Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED201008
63629-3868-2Ciprofloxacin28 in 1 BOTTLETABLET, FILM COATED281008
63629-3868-3Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED141008
63629-3868-4Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED301008
63629-3868-5Ciprofloxacin60 in 1 BOTTLETABLET, FILM COATED601008
63629-3868-6Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED101008
63629-3868-7Ciprofloxacin90 in 1 BOTTLETABLET, FILM COATED901008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3868-1EA - Each63629-3868b636fbbf-4add-45df-8eba-08fd8dda3fec12012-07-24
63629-3868-2EA - Each63629-38689b1e94ca-a31d-49ce-94e8-06432beb9d9912012-07-24
63629-3868-3EA - Each63629-3868daa8327c-67d6-4a30-88db-1ca71871131112012-07-24
63629-3868-4EA - Each63629-386808b487ab-acca-41c8-9a11-66b31121d6c712015-02-02
63629-3868-5EA - Each63629-3868c844ba87-ec9d-4e07-b7ba-0e0d422f93a612015-02-02
63629-3868-6EA - Each63629-38683824f8a8-bae6-42fe-b51d-0c046d74d21412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACINACTIVE INGREDIENT5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
TALCINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3868CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1008Current NDC, Legacy NDC, 7 package rows20240511_a57066d7-dc2c-d2d0-b003-d9143fcca1c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197512ciprofloxacin 750 MG Oral TabletPSNa57066d7-dc2c-d2d0-b003-d9143fcca1c51008
197512ciprofloxacin 750 MG Oral TabletSCDa57066d7-dc2c-d2d0-b003-d9143fcca1c51008
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSYa57066d7-dc2c-d2d0-b003-d9143fcca1c51008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-3868-16362938680120 TABLET, FILM COATED in 1 BOTTLE (63629-3868-1) 2008-10-300000-00-00NoNoCurrent
63629-3868-26362938680228 TABLET, FILM COATED in 1 BOTTLE (63629-3868-2) 2009-06-120000-00-00NoNoCurrent
63629-3868-36362938680314 TABLET, FILM COATED in 1 BOTTLE (63629-3868-3) 2013-04-230000-00-00NoNoCurrent
63629-3868-46362938680430 TABLET, FILM COATED in 1 BOTTLE (63629-3868-4) 2011-07-260000-00-00NoNoCurrent
63629-3868-56362938680560 TABLET, FILM COATED in 1 BOTTLE (63629-3868-5) 2010-12-140000-00-00NoNoCurrent
63629-3868-66362938680610 TABLET, FILM COATED in 1 BOTTLE (63629-3868-6) 2013-12-030000-00-00NoNoCurrent
63629-3868-76362938680790 TABLET, FILM COATED in 1 BOTTLE (63629-3868-7) 2023-03-060000-00-00NoNoCurrent