FDA.reportPublic FDA data

Ciprofloxacin hydrochloride

Product NDC
10544-606
11-digit product format
105440606
Labeler code
10544
Product ID
10544-606_025bb816-e2c4-416d-bba4-fb833f8496d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA076089
Marketing category
ANDA
Marketing start
2010-05-17
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-606-062019-10-21C16284748780-1956f9ecf-c489-621f-e053-dbdaa90a74adCIPROFLOXACIN TABLETS USP Rx only
10544-606-102019-10-21C16284748780-1956f9ecf-c489-621f-e053-dbdaa90a74adCIPROFLOXACIN TABLETS USP Rx only
10544-606-142019-10-21C16284748780-1956f9ecf-c489-621f-e053-dbdaa90a74adCIPROFLOXACIN TABLETS USP Rx only
10544-606-152019-10-21C16284748780-1956f9ecf-c489-621f-e053-dbdaa90a74adCIPROFLOXACIN TABLETS USP Rx only
10544-606-202019-10-21C16284748780-1956f9ecf-c489-621f-e053-dbdaa90a74adCIPROFLOXACIN TABLETS USP Rx only
10544-606-422019-10-21C16284748780-1956f9ecf-c489-621f-e053-dbdaa90a74adCIPROFLOXACIN TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-606-06Ciprofloxacin hydrochloride6 in 1 BOTTLETABLET62
10544-606-10Ciprofloxacin hydrochloride10 in 1 BOTTLETABLET102
10544-606-14Ciprofloxacin hydrochloride14 in 1 BOTTLETABLET142
10544-606-15Ciprofloxacin hydrochloride15 in 1 BOTTLETABLET152
10544-606-20Ciprofloxacin hydrochloride20 in 1 BOTTLETABLET202
10544-606-42Ciprofloxacin hydrochloride42 in 1 BOTTLETABLET422

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-606-10EA - Each10544-606e42997b3-7502-4d0e-a04e-dc02138c06d012015-02-02
10544-606-14EA - Each10544-606b8427d54-dfb1-4aca-8b51-6e746a0bd76d12015-02-02
10544-606-20EA - Each10544-606192ce610-f321-4c97-9b30-a690446d944512015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
CiprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-606CIPROFLOXACIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 6 package rows20100917_4144009e-e956-4fec-b5b7-a4950168e055.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN4144009e-e956-4fec-b5b7-a4950168e0552
309309ciprofloxacin 500 MG Oral TabletSCD4144009e-e956-4fec-b5b7-a4950168e0552
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY4144009e-e956-4fec-b5b7-a4950168e0552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-606-06105440606066 in 1 BOTTLEHistorical
10544-606-101054406061010 in 1 BOTTLEHistorical
10544-606-141054406061414 in 1 BOTTLEHistorical
10544-606-151054406061515 in 1 BOTTLEHistorical
10544-606-201054406062020 in 1 BOTTLEHistorical
10544-606-421054406064242 in 1 BOTTLEHistorical