FDA.reportPublic FDA data

ciprofloxacin

Product NDC
63187-990
11-digit product format
631870990
Labeler code
63187
Product ID
63187-990_d0f31dff-c2dd-487d-a329-342765d135e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076639
Marketing category
ANDA
Marketing start
2004-09-10
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
750 mg/1
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
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
63187-990-06ciprofloxacin06 in 1 BOTTLETABLET064
63187-990-07ciprofloxacin07 in 1 BOTTLETABLET074
63187-990-10ciprofloxacin10 in 1 BOTTLETABLET104
63187-990-14ciprofloxacin14 in 1 BOTTLETABLET144
63187-990-28ciprofloxacin28 in 1 BOTTLETABLET284
63187-990-30ciprofloxacin30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-990-10EA - Each63187-990b2ff727c-97bc-41ae-aa8f-1b756109fa4412018-05-09
63187-990-30EA - Each63187-9905da584a4-3d1d-495a-a83e-f441dea6199d12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-990CIPROFLOXACIN TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20200229_4af3894a-8945-4b2d-bdf6-a83bbd415b89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197512ciprofloxacin 750 MG Oral TabletPSN4af3894a-8945-4b2d-bdf6-a83bbd415b894
197512ciprofloxacin 750 MG Oral TabletSCD4af3894a-8945-4b2d-bdf6-a83bbd415b894
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY4af3894a-8945-4b2d-bdf6-a83bbd415b894

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-990-06631870990066 TABLET in 1 BOTTLE (63187-990-06) 6 tablet2018-03-010000-00-00NoNoCurrent
63187-990-07631870990077 TABLET in 1 BOTTLE (63187-990-07) 7 tablet2018-03-010000-00-00NoNoCurrent
63187-990-106318709901010 TABLET in 1 BOTTLE (63187-990-10) 10 tablet2018-03-010000-00-00NoNoCurrent
63187-990-146318709901414 TABLET in 1 BOTTLE (63187-990-14) 14 tablet2018-03-010000-00-00NoNoCurrent
63187-990-286318709902828 TABLET in 1 BOTTLE (63187-990-28) 28 tablet2018-03-010000-00-00NoNoCurrent
63187-990-306318709903030 TABLET in 1 BOTTLE (63187-990-30) 30 tablet2018-03-010000-00-00NoNoCurrent