Ciprofloxacin

Product NDC
72789-511
11-digit product format
727890511
Labeler code
72789
Product ID
72789-511_536e90a0-ea8d-5f02-e063-6394a90a9cee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077859
Marketing category
ANDA
Marketing start
2024-02-09
Marketing end
2028-02-29
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077859-001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26
A077859-002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26
A077859-003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077859-001AB
A077859-002AB
A077859-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-2684e616aacf4f…
2026-09-14 22:38:342026-08A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-2684e616aacf4f…
2026-09-14 22:38:342026-08A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-2684e616aacf4f…
2026-08-18 06:07:402026-07A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077859-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077859-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077859-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077859-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077859-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077859-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077859-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077859-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077859-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077859-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077859-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077859-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077859-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077859-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077859-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077859-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077859-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077859-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077859-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077859-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077859-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077859-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077859-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077859-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077859-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077859-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077859-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077859-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077859-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077859-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077859-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077859-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077859-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077859-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077859-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077859-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077859-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077859-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077859-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077859-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4BA73M5E37Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309309Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a914512b-9a4a-4c53-ab7a-2e2b1ea8a012Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-511-10Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED107
72789-511-14Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED147
72789-511-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED207
72789-511-30Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-511-10EA - Each72789-511eae8b96e-86de-4864-948d-24043b0a5a9b12025-10-14
72789-511-14EA - Each72789-511e0b1463c-ab26-4a56-8a28-19226e555dbc12025-09-12
72789-511-20EA - Each72789-511e2e18efb-ba67-44f2-a766-015bcd04cc1912025-10-14
72789-511-30EA - Each72789-511dd700612-2198-450f-9e68-195678a6be5012025-07-08

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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3c611c8c-deed-4904-93f7-f75a2147fbf72025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAurobindo Pharma Limited7041828f-d4ec-4813-bcac-cb335c6c312a2025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAurobindo Pharma Limited2b3b6a9f-259c-4736-b88f-f49d1eb642862025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutionscc768d3e-a7cc-46a2-ae6d-0f5eb2f054062025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.1cb05412-372e-4b49-92e1-532caa05f38f2025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEProficient Rx LPec337816-4f48-4d04-b91d-60f9f5f634da2024-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEProficient Rx LP9ee1f252-a64e-4b72-a6f7-60298e8272222022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4e74496f-4dca-4471-be32-c0a14bc627502018-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNa914512b-9a4a-4c53-ab7a-2e2b1ea8a0127
309309ciprofloxacin 500 MG Oral TabletSCDa914512b-9a4a-4c53-ab7a-2e2b1ea8a0127
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa914512b-9a4a-4c53-ab7a-2e2b1ea8a0127

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-511-107278905111010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-10) 2025-08-272028-02-29NoNoHistorical
72789-511-147278905111414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-14) 2025-07-312028-02-29NoNoHistorical
72789-511-207278905112020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-20) 2025-09-122028-02-29NoNoHistorical
72789-511-307278905113030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-30) 2025-06-022028-02-29NoNoHistorical