FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
25021-114
11-digit product format
250210114
Labeler code
25021
Product ID
25021-114_c30953aa-a1e5-45b5-97a5-6bb9d0b0bd6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA078252
Marketing category
ANDA
Marketing start
2008-03-24
Substance
CIPROFLOXACIN
Active strength
2 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [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
CIPROFLOXACIN2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5E8K9I0O4U
Rxcui1665210, 1665212

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
25021-114-82Ciprofloxacin24 in 1 CARTONINJECTION, SOLUTION2424
25021-114-82Ciprofloxacin1 in 1 POUCHINJECTION, SOLUTION124
25021-114-87Ciprofloxacin24 in 1 CARTONINJECTION, SOLUTION2424
25021-114-87Ciprofloxacin1 in 1 POUCHINJECTION, SOLUTION124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-114-82ML - Milliliter25021-114bffbfa0b-fdda-4151-bbe7-ba608c417e1812012-07-24
25021-114-87ML - Milliliter25021-11435f03c96-06e6-4250-ba45-0aae2fafb04f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciprofloxacinACTIVE INGREDIENT5E8K9I0O4UCIPROFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
dextrose monohydrateINACTIVE INGREDIENTLX22YL083GCIPROFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
hydrochloric acidINACTIVE INGREDIENTQTT17582CBCIPROFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
lactic acidINACTIVE INGREDIENT33X04XA5ATCIPROFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
waterINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-114CIPROFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]24Current NDC, Legacy NDC, 4 package rows20230322_7049f870-6741-4a67-8033-398c36126a06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665210ciprofloxacin 200 MG in 100 ML InjectionPSN7049f870-6741-4a67-8033-398c36126a0624
1665212ciprofloxacin 400 MG in 200 ML InjectionPSN7049f870-6741-4a67-8033-398c36126a0624
1665210100 ML ciprofloxacin 2 MG/ML InjectionSCD7049f870-6741-4a67-8033-398c36126a0624
1665212200 ML ciprofloxacin 2 MG/ML InjectionSCD7049f870-6741-4a67-8033-398c36126a0624
1665210ciprofloxacin 200 MG per 100 ML InjectionSY7049f870-6741-4a67-8033-398c36126a0624
1665212ciprofloxacin 400 MG per 200 ML InjectionSY7049f870-6741-4a67-8033-398c36126a0624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-114-662502101146624 POUCH in 1 CARTON (25021-114-66) > 1 BAG in 1 POUCH > 200 mL in 1 BAG24 pouch2022-12-150000-00-00NoNoCurrent
25021-114-822502101148224 POUCH in 1 CARTON (25021-114-82) / 1 BAG in 1 POUCH / 100 mL in 1 BAG24 pouch2008-03-240000-00-00NoNoCurrent
25021-114-872502101148724 POUCH in 1 CARTON (25021-114-87) / 1 BAG in 1 POUCH / 200 mL in 1 BAG24 pouch2008-03-240000-00-00NoNoCurrent