Ciprofloxacin

Product NDC
0781-3239
11-digit product format
007813239
Labeler code
0781
Product ID
0781-3239_ad3c44ea-73db-44d7-b11f-d1fa82d968e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA078252
Marketing category
ANDA
Marketing start
2008-03-24
Marketing end
0000-00-00
Substance
CIPROFLOXACIN
Active strength
2 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-3239DDiscontinued by firm2026-08-17
excluded packagepackage0781-32390781-3239-09DDiscontinued by firm2026-08-17

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 1 · 24 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 packagepackage0781-3239-09d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-3239-09f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-3239-092ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-3239-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-3239-09cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-3239-09cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-3239-09302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-3239-09ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-3239-090efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-3239-09ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-3239-09367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-3239-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN200MG/100MLINJECTABLE / INJECTIONAP2008-03-18
A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN400MG/200MLINJECTABLE / INJECTIONAP2008-03-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A078252-001AP
A078252-002AP

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-18bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078252-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A078252-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078252-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078252-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078252-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078252-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078252-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078252-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078252-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078252-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078252-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078252-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078252-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078252-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078252-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078252-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078252-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078252-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078252-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078252-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078252-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078252-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078252-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078252-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078252-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078252-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078252-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078252-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078252-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078252-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078252-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078252-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078252-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078252-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078252-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078252-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078252-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078252-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078252-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078252-002AP1bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3239-09ML - Milliliter0781-323955d22f44-4b49-4232-93e8-0dbc9b32cbc812013-02-13
0781-3239-46ML - Milliliter0781-3239d50a1dd2-1999-475c-bb8b-c2f9da4f7cc012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACINACTIVE INGREDIENT5E8K9I0O4UCIPROFLOXACIN INJECTION [SANDOZ INC]12
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN INJECTION [SANDOZ INC]12
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GCIPROFLOXACIN INJECTION [SANDOZ INC]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCIPROFLOXACIN INJECTION [SANDOZ INC]12
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATCIPROFLOXACIN INJECTION [SANDOZ INC]12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciprofloxacin in DextroseCIPROFLOXACINProPharma Distribution42c758be-4d44-018a-e063-6294a90ae0412025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078252
application number: ANDA078252
Ciprofloxacin in DextroseCIPROFLOXACINHospira, Inc.cbbbf939-3219-4515-a48e-ca264daa4d072025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078252
application number: ANDA078252
CiprofloxacinCIPROFLOXACINSagent Pharmaceuticals7049f870-6741-4a67-8033-398c36126a062022-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078252
application number: ANDA078252