Ciprofloxacin

Product NDC
0378-7098
11-digit product format
003787098
Labeler code
0378
Product ID
0378-7098_047b0734-7d92-4f9a-9830-0e14a7008e6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075817
Marketing category
ANDA
Marketing start
2009-03-09
Marketing end
2021-12-31
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7098-01EA - Each0378-7098e737e0ea-8523-468d-aa28-263d2bdc644b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACINACTIVE INGREDIENT5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIPROFLOXACIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECIPROFLOXACIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CIPROFLOXACIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN88ee9c0e-aa2a-47ce-b649-25bfa6fc8a7b1
309309ciprofloxacin 500 MG Oral TabletPSNa974ef05-1cc3-4cbc-a0b4-36b46ed107c91
309309ciprofloxacin 500 MG Oral TabletPSNc14a40f7-6cd7-49c2-9e66-27cbff6122571
309309ciprofloxacin 500 MG Oral TabletSCD88ee9c0e-aa2a-47ce-b649-25bfa6fc8a7b1
309309ciprofloxacin 500 MG Oral TabletSCDa974ef05-1cc3-4cbc-a0b4-36b46ed107c91
309309ciprofloxacin 500 MG Oral TabletSCDc14a40f7-6cd7-49c2-9e66-27cbff6122571
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY88ee9c0e-aa2a-47ce-b649-25bfa6fc8a7b1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa974ef05-1cc3-4cbc-a0b4-36b46ed107c91
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYc14a40f7-6cd7-49c2-9e66-27cbff6122571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-7098-0100378709801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7098-01) 2009-03-092021-12-31NoNoCurrent