Ciprofloxacin

Product NDC
60760-689
Requested package NDC
60760-689-10
11-digit product format
607600689
Labeler code
60760
Product ID
60760-689_4574adeb-9095-09d4-e063-6394a90a7e75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofolxacin
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA208921
Marketing category
ANDA
Marketing start
2023-10-01
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
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 1.

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
A208921-001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-22
A208921-002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208921-001AB
A208921-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208921-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2018-06-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A208921-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2018-06-22782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208921-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208921-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208921-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208921-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208921-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208921-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208921-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208921-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208921-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208921-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208921-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208921-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208921-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208921-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208921-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208921-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208921-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208921-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208921-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208921-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208921-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208921-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208921-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208921-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208921-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208921-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208921-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208921-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208921-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208921-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208921-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208921-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208921-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208921-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208921-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208921-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208921-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208921-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208921-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208921-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin
Listing expiration
2027-12-31

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
24c43000-7620-3869-e063-6394a90a9631Available 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
60760-689-10Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET103
60760-689-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-689-10EA - Each60760-689c8f91f47-8d62-4a32-aabf-0190a2744a5d12025-01-14
60760-689-20EA - Each60760-689810b38be-efa4-44cc-b220-28e9916f01c612024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-689CIPROFLOXACIN (CIPROFOLXACIN) TABLET [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, 2 package rows20241211_24c43000-7620-3869-e063-6394a90a9631.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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFOLXACINREMEDYREPACK INC.c527d138-e32c-418f-9573-a3d8a796279f2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFLOXACINSt. Mary's Medical Park Pharmacy348e810c-e572-f3d2-e063-6394a90a08552026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFOLXACINAsclemed USA, Inc.c4eecdf8-9e50-4e44-aca1-b9c19317d52a2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFLOXACINSt. Mary's Medical Park Pharmacyc32ccb5f-b9d7-0aff-e053-2995a90afe6d2026-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFOLXACINST. MARY'S MEDICAL PARK PHARMACY24c43000-7620-3869-e063-6394a90a96312026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
ndc (package): 60760-689-10
ndc (product): 60760-689
ndc11 (package): 60760068910
CiprofloxacinCIPROFLOXACINBryant Ranch Prepack5af16acc-51ce-41ed-b1c4-6b3fb38ef5152026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFLOXACINBryant Ranch Prepacka05035e1-f941-4f7c-9321-91dd50ab149b2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFOLXACINSportpharm LLCd38b5160-4c1c-41d9-8f13-f9f877778f9c2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFOLXACINREMEDYREPACK INC.4edc4fda-7834-46cc-a0ed-22f117e6e10b2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFOLXACINProficient Rx LP9f00ae9d-8707-4275-9eba-2ed72db8aea12026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFOLXACINPreferred Pharmaceuticals Inc.4425d454-210d-4b9f-88ad-6b32a9e0d3bd2026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFLOXACINPreferred Pharmaceuticals Inc.18414c5a-8153-44f7-b27a-90c290af0a232026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.c2d8dcc9-23b0-75bb-e053-2995a90a02c82026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFLOXACINDirect_Rx351b41db-622f-a1eb-e063-6294a90a56672026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.bf52e242-199b-4206-e053-2a95a90a1eb72026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.bf8d4359-a850-97b7-e053-2a95a90aa66a2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFLOXACINNorthwind Health Company, LLCf6debb60-d885-230b-e053-6394a90ad73a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFLOXACIN TABLETSYiling Pharmaceutical, Inc.6fd3da0b-7428-ac8f-e053-2a91aa0aed9f2025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFOLXACINRedpharm Drug3253a41f-4f0a-5d83-e063-6294a90a890c2025-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921
CiprofloxacinCIPROFOLXACINNuCare Pharmaceutical, Inc.24760182-4be8-9f43-e063-6294a90a269e2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208921
application number: ANDA208921

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN24c43000-7620-3869-e063-6394a90a96313
309309ciprofloxacin 500 MG Oral TabletSCD24c43000-7620-3869-e063-6394a90a96313
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY24c43000-7620-3869-e063-6394a90a96313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-689-106076006891010 TABLET in 1 BOTTLE, PLASTIC (60760-689-10) 10 tablet2024-12-05NoNoCurrent