Ciprofloxacin

Product NDC
85534-0047
11-digit product format
855340047
Labeler code
85534
Product ID
85534-0047_56776b15-35d3-3952-e063-6294a90a91e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HAWAII REPACK, INC.
Application
ANDA077859
Marketing category
ANDA
Marketing start
2007-04-26
Marketing end
2027-02-28
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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197511Internal RxNorm lookup
197512Internal RxNorm lookup
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
0fe3becb-f90e-4187-a8e8-bd0de5a79ad2Available on FDA.report

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.47d1e4c5-f669-4aca-9e8c-0d6bb833b8592026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDERedpharm Drug57e5832f-9168-1f24-e063-6294a90aaae62026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEHAWAII REPACK, INC.0fe3becb-f90e-4187-a8e8-bd0de5a79ad22026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
ndc (product): 85534-0047
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.a2ffa81a-86c5-40b9-8fa0-c889801ef4792026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.a914512b-9a4a-4c53-ab7a-2e2b1ea8a0122026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAurobindo Pharma Limited6a935846-3c97-4517-bc4e-2377f673285e2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutionsd8b21832-b74f-4f85-a304-b907c9e01e722026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions9d83b127-ef13-4b2c-aa30-0f54937dc2402026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAmerican Health Packaging275de35b-5c97-4ff8-a571-42e23c1cd83e2026-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAsclemed USA, Inc.ae77a5c0-a2ae-770c-e053-2a95a90a6a962026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
Ciprofloxacin HCLCIPROFLOXACIN HCLAdvanced Rx Pharmacy of Tennessee, LLCe237dd23-faf3-1765-e053-2a95a90ae62d2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs26e2d370-f59c-40ae-9c1e-7f8bf1f9fde42026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAmerican Health Packaging0fac4466-fbe5-49d2-96e3-e3ac2739bd5b2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CIPROFLOXACINCIPROFLOXACIN HYDROCHLORIDEDIRECT RXa7e5174a-dd01-6050-e053-2a95a90add3f2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACINDirect_Rx36d6c27d-45dc-3081-e063-6394a90a87e92026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDENorthwind Health Company, LLC2f123a2c-3f94-ca2d-e063-6394a90aff682026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDENorthwind Health Company, LLCf80ab01d-2533-1b4c-e053-6294a90a6e6a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACINQPharma Inc4d5afeff-3917-43e1-9d12-d70ccab00dcc2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepackac87e3c7-1e51-4dd1-8b75-dec6536810e32025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepackec43739e-7154-45a7-add7-bfb8fb779be82025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
85534-0047-0855340047006 TABLET, FILM COATED in 1 BOTTLE (85534-0047-0) 2007-04-262027-02-28NoNoHistorical
85534-0047-18553400470110 TABLET, FILM COATED in 1 BOTTLE (85534-0047-1) 2007-04-262027-02-28NoNoHistorical
85534-0047-28553400470214 TABLET, FILM COATED in 1 BOTTLE (85534-0047-2) 2007-04-262027-02-28NoNoHistorical
85534-0047-38553400470320 TABLET, FILM COATED in 1 BOTTLE (85534-0047-3) 2007-04-262027-02-28NoNoHistorical
85534-0047-48553400470421 TABLET, FILM COATED in 1 BOTTLE (85534-0047-4) 2007-04-262027-02-28NoNoHistorical
85534-0047-58553400470528 TABLET, FILM COATED in 1 BOTTLE (85534-0047-5) 2007-04-262027-02-28NoNoHistorical
85534-0047-68553400470630 TABLET, FILM COATED in 1 BOTTLE (85534-0047-6) 2007-04-262027-02-28NoNoHistorical