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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13913-001IInactivated by FDA2026-08-03
excluded packagepackage13913-00113913-001-03IInactivated by FDA2026-08-03
excluded packagepackage13913-00113913-001-30IInactivated by FDA2026-08-03
excluded packagepackage13913-00113913-001-91IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021744-001PROQUIN XRCIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19a50c72e98297…

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