Ciprofloxacin

Product NDC
60760-689
Requested package NDC
60760-689-20
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…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 60760-689-20
ndc (product): 60760-689
ndc11 (package): 60760068920
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

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

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
60760-689-206076006892020 TABLET in 1 BOTTLE, PLASTIC (60760-689-20) 20 tablet2024-10-10NoNoCurrent