FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
43063-547
11-digit product format
430630547
Labeler code
43063
Product ID
43063-547_42ef2624-a5bf-f4f7-e063-6294a90a1400
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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
Rxcui309309

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
43063-547-01Ciprofloxacin100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10031
43063-547-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2031
43063-547-82Ciprofloxacin500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-547-01EA - Each43063-5472e90d21c-03ad-4584-94b9-02174db336a212019-02-13
43063-547-02EA - Each43063-54787af93ea-d3ee-4abb-b919-a2cf0ae5305c12015-08-04
43063-547-03EA - Each43063-547c3024e42-e58b-4db5-b72a-2367bf48e99912016-03-04
43063-547-04EA - Each43063-547347ceb6f-804e-493b-8ea3-c4f14a7549e512016-03-04
43063-547-06EA - Each43063-547f24ffd5d-c95c-406e-8754-b8cce0c80dec12015-09-10
43063-547-10EA - Each43063-547da48accc-0f67-44b5-ac76-a843dc98ac8212015-01-05
43063-547-14EA - Each43063-547f560f7c5-f008-4478-b484-4d1daacd893012015-11-12
43063-547-20EA - Each43063-547ddf5dba9-0bb5-4d1f-8c78-7fdacbdb812412015-01-05
43063-547-28EA - Each43063-54775db15ad-23e3-42a6-8e0f-35cb8944787212019-01-24
43063-547-30EA - Each43063-5472138bd30-9468-4078-91fa-053ddbea2b0c12015-01-05
43063-547-79EA - Each43063-547974a3b0d-12d0-4382-8e70-7cc4b9764b5f12015-11-12
43063-547-82EA - Each43063-5476fa24984-c73d-4e63-859c-de53fc06ac3e12020-06-05

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-547CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]30Current NDC, Legacy NDC, 3 package rows20250305_74e2dd24-5c6e-4dde-a2ab-f2d2e61734d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 TabletPSNc7bc0d20-526c-48ea-b23a-cea9eb7080ff1
309309ciprofloxacin 500 MG Oral TabletSCDc7bc0d20-526c-48ea-b23a-cea9eb7080ff1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYc7bc0d20-526c-48ea-b23a-cea9eb7080ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-547-0143063054701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-01) 2019-01-070000-00-00NoNoCurrent
43063-547-02430630547022 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-02) 2015-07-060000-00-00NoNoCurrent
43063-547-03430630547033 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-03) 2016-01-290000-00-00NoNoCurrent
43063-547-04430630547044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-04) 2015-11-170000-00-00NoNoCurrent
43063-547-06430630547066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-06) 2015-12-070000-00-00NoNoCurrent
43063-547-104306305471010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-10) 2014-11-050000-00-00NoNoCurrent
43063-547-144306305471414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-14) 2015-09-080000-00-00NoNoCurrent
43063-547-204306305472020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-20) 2014-11-050000-00-00NoNoCurrent
43063-547-284306305472828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-28) 2017-01-120000-00-00NoNoCurrent
43063-547-304306305473030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-30) 2014-11-050000-00-00NoNoCurrent
43063-547-79430630547791 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-79) 2015-08-310000-00-00NoNoCurrent
43063-547-8243063054782500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-82) 2020-05-210000-00-00NoNoCurrent