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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13913-001IInactivated by FDA2026-09-09
excluded packagepackage13913-00113913-001-03IInactivated by FDA2026-09-09
excluded packagepackage13913-00113913-001-30IInactivated by FDA2026-09-09
excluded packagepackage13913-00113913-001-91IInactivated by FDA2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 88 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13913-001-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13913-001-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13913-001-91d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13913-001-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13913-001-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13913-001-91f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13913-001-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13913-001-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13913-001-912ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13913-001-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13913-001-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13913-001-91a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13913-001-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13913-001-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13913-001-91cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13913-001-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13913-001-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13913-001-91cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13913-001-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13913-001-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13913-001-91302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13913-001-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13913-001-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13913-001-91ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13913-001-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13913-001-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13913-001-910efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13913-001-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13913-001-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13913-001-91ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13913-001-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13913-001-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13913-001-91367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13913-001-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13913-001-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13913-001-91557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage13913-001-038af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage13913-001-308af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage13913-001-918af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage13913-001-03834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage13913-001-30834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage13913-001-91834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage13913-001-031332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage13913-001-301332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage13913-001-911332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-193f01610625f2…
2019-09-15 20:21 UTC2019-09N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19e64feba35796…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021744-00164889622020-06-20Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021744-00164889622020-06-20Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021744-00164889622020-06-20Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021744-00164889622020-06-20Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021744-00164889622020-06-20Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021744-00164889622020-06-20Drug productea99ee380514…

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#

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#

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