FDA.reportPublic FDA data

Proquin

Product NDC
13913-001
11-digit product format
139130001
Labeler code
13913
Product ID
13913-001_916845b4-dd49-4c20-a5e9-9a792a788963
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Depomed, Inc.
Application
NDA021744
Marketing category
NDA
Marketing start
2005-10-01
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
13913-001-032019-10-21C16284748780-1956f9ecf-cd1d-621f-e053-dbdaa90a74adProquin ® XR (ciprofloxacin hydrochloride) Extended-Release Tablets, 500 mg
13913-001-302019-10-21C16284748780-1956f9ecf-cd1d-621f-e053-dbdaa90a74adProquin ® XR (ciprofloxacin hydrochloride) Extended-Release Tablets, 500 mg
13913-001-912019-10-21C16284748780-1956f9ecf-cd1d-621f-e053-dbdaa90a74adProquin ® XR (ciprofloxacin hydrochloride) Extended-Release Tablets, 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13913-001-03ProquinXR1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE12
13913-001-03ProquinXR3 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE32
13913-001-30ProquinXR30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
13913-001-91ProquinXR1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE12
13913-001-91ProquinXR1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13913-001-03EA - Each13913-0010f073d9c-a9fd-477f-aa95-9e3ab219f55012012-07-24
13913-001-30EA - Each13913-00134030fc9-a790-4bcc-aa7e-3da36a7317ba12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37PROQUIN XR (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]2
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UPROQUIN XR (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROQUIN XR (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APROQUIN XR (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPROQUIN XR (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13913-001PROQUIN XR (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPOMED, INC.]2Legacy NDC, 5 package rows20100817_ff17b6d9-4a76-4cce-af88-aa8316018be6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359383ciprofloxacin 500 MG 24HR Extended Release Oral TabletPSNff17b6d9-4a76-4cce-af88-aa8316018be62
672912Proquin XR 500 MG 24HR Extended Release Oral TabletPSNff17b6d9-4a76-4cce-af88-aa8316018be62
67291224 HR ciprofloxacin 500 MG Extended Release Oral Tablet [Proquin]SBDff17b6d9-4a76-4cce-af88-aa8316018be62
35938324 HR ciprofloxacin 500 MG Extended Release Oral TabletSCDff17b6d9-4a76-4cce-af88-aa8316018be62
67291224 HR Proquin 500 MG Extended Release Oral TabletSYff17b6d9-4a76-4cce-af88-aa8316018be62
359383ciprofloxacin 500 MG 24 HR Extended Release Oral TabletSYff17b6d9-4a76-4cce-af88-aa8316018be62
672912Proquin 500 MG 24 HR Extended Release Oral TabletSYff17b6d9-4a76-4cce-af88-aa8316018be62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
13913-001-03139130001031 in 1 CARTONHistorical
13913-001-301391300013030 in 1 BOTTLEHistorical
13913-001-91139130001911 in 1 CARTONHistorical