Ciprofloxacin

Product NDC
25021-192
11-digit product format
250210192
Labeler code
25021
Product ID
25021-192_4f039d85-dab5-4f6e-8a0f-087a4c47b089
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA078252
Marketing category
ANDA
Marketing start
2022-12-15
Substance
CIPROFLOXACIN
Active strength
2 mg/mL
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5E8K9I0O4UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1665210Internal RxNorm lookup
1665212Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f406e796-17d9-4465-b8a7-00d966a4ba74Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-192-82Ciprofloxacin24 in 1 CARTONINJECTION, SOLUTION243
25021-192-82Ciprofloxacin1 in 1 POUCHINJECTION, SOLUTION13
25021-192-87Ciprofloxacin24 in 1 CARTONINJECTION, SOLUTION243
25021-192-87Ciprofloxacin1 in 1 POUCHINJECTION, SOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-192-82ML - Milliliter25021-192a1cc8130-954e-4c2b-9d0f-ee30ed2d25bb12023-05-05
25021-192-87ML - Milliliter25021-1921e88e9fd-7592-4174-9a33-3b0f249b997012023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-192CIPROFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]3Current NDC, Legacy NDC, 4 package rows20241102_f406e796-17d9-4465-b8a7-00d966a4ba74.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665210ciprofloxacin 200 MG in 100 ML InjectionPSNf406e796-17d9-4465-b8a7-00d966a4ba743
1665212ciprofloxacin 400 MG in 200 ML InjectionPSNf406e796-17d9-4465-b8a7-00d966a4ba743
1665210100 ML ciprofloxacin 2 MG/ML InjectionSCDf406e796-17d9-4465-b8a7-00d966a4ba743
1665212200 ML ciprofloxacin 2 MG/ML InjectionSCDf406e796-17d9-4465-b8a7-00d966a4ba743
1665210ciprofloxacin 200 MG per 100 ML InjectionSYf406e796-17d9-4465-b8a7-00d966a4ba743
1665212ciprofloxacin 400 MG per 200 ML InjectionSYf406e796-17d9-4465-b8a7-00d966a4ba743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-192-822502101928224 POUCH in 1 CARTON (25021-192-82) / 1 BAG in 1 POUCH / 100 mL in 1 BAG24 pouch2022-12-150000-00-00NoNoCurrent
25021-192-872502101928724 POUCH in 1 CARTON (25021-192-87) / 1 BAG in 1 POUCH / 200 mL in 1 BAG24 pouch2022-12-150000-00-00NoNoCurrent