Ciprofloxacin

Product NDC
70518-3063
11-digit product format
705183063
Labeler code
70518
Product ID
70518-3063_4e90dbf6-0991-5bab-e063-6394a90aacf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076558
Marketing category
ANDA
Marketing start
2021-04-02
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-306370518-3063-0DDiscontinued by firm2026-08-17
excluded packagepackage70518-306370518-3063-1DDiscontinued by firm2026-08-17
excluded packagepackage70518-306370518-3063-2DDiscontinued by firm2026-08-17
excluded packagepackage70518-306370518-3063-3DDiscontinued by firm2026-08-17
excluded packagepackage70518-306370518-3063-4DDiscontinued by firm2026-08-17
excluded packagepackage70518-306370518-3063-5DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 34 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-3063-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-3063-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-3063-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-3063-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-3063-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-3063-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-3063-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-3063-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3170518-3063-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3170518-3063-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-3063-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2870518-3063-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2870518-3063-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-3063-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2170518-3063-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2170518-3063-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-3063-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1070518-3063-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1070518-3063-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170518-3063-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3170518-3063-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3170518-3063-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070518-3063-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2070518-3063-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2070518-3063-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070518-3063-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1070518-3063-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1070518-3063-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870518-3063-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0870518-3063-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0870518-3063-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370518-3063-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0370518-3063-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0370518-3063-0367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076558-002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-09
A076558-003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-09
A076558-004CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-09

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-091e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076558-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076558-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076558-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076558-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076558-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076558-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076558-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076558-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076558-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076558-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076558-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076558-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076558-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076558-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076558-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076558-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076558-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076558-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076558-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076558-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076558-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076558-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076558-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076558-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076558-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076558-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076558-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076558-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076558-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076558-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076558-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076558-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076558-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076558-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076558-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076558-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076558-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076558-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076558-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076558-002AB18072bd15b7f6…

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
44b6cefc-7638-4437-95e7-8f239f66a9d4Available 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
70518-3063-0Ciprofloxacin30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-3063-1Ciprofloxacin14 in 1 BLISTER PACKTABLET, FILM COATED1414
70518-3063-2Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2014
70518-3063-3Ciprofloxacin20 in 1 BLISTER PACKTABLET, FILM COATED2014
70518-3063-4Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1414
70518-3063-5Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1014
70518-3063-6Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3063CIPROFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 7 package rows20240926_44b6cefc-7638-4437-95e7-8f239f66a9d4.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFLOXACINREMEDYREPACK INC.44b6cefc-7638-4437-95e7-8f239f66a9d42026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
ndc (product): 70518-3063
CiprofloxacinCIPROFLOXACINREMEDYREPACK INC.c08b37c3-5f01-47ed-9508-02813bbd008b2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.3b9b15f7-354b-4049-982b-f6f31751a8852026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINNorthwind Health Company, LLCf67d727f-b9ca-aec0-e053-2995a90aab692026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.fa32aafd-e3f5-4be6-9413-c7663c1c2cec2025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.5723eaf9-8659-4730-b792-4e4c33690ccb2025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.d275175c-691a-4d09-bbb7-50ee819e67272025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CIPROFLOXACINCIPROFLOXACINDirectRxd23e359d-6d12-38f6-e053-2a95a90a0a882025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINDirectRxd358eb18-f4d0-e9ba-e053-2a95a90a435d2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINGolden State Medical Supply, Inc.2e1addcf-6d5b-46c8-812b-558fd847f0052025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINHikma Pharmaceuticals USA Inc.3b3d22dc-df09-4910-8c9b-1204eeedbd682024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINBryant Ranch Prepack4f600112-168a-4a58-9914-7c01f71894da2024-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINBryant Ranch Prepacka57066d7-dc2c-d2d0-b003-d9143fcca1c52024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINAsclemed USA, Inc.1bb1d26e-fad0-4338-8948-3f095d5817a62022-03-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN44b6cefc-7638-4437-95e7-8f239f66a9d414
309309ciprofloxacin 500 MG Oral TabletSCD44b6cefc-7638-4437-95e7-8f239f66a9d414
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY44b6cefc-7638-4437-95e7-8f239f66a9d414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3063-07051830630030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3063-0) 2021-04-020000-00-00NoNoCurrent
70518-3063-17051830630114 TABLET, FILM COATED in 1 BLISTER PACK (70518-3063-1) 2021-04-280000-00-00NoNoCurrent
70518-3063-27051830630220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-2) 2021-05-240000-00-00NoNoCurrent
70518-3063-37051830630320 TABLET, FILM COATED in 1 BLISTER PACK (70518-3063-3) 2021-06-040000-00-00NoNoCurrent
70518-3063-47051830630414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-4) 2021-07-210000-00-00NoNoCurrent
70518-3063-57051830630510 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-5) 2022-05-090000-00-00NoNoCurrent
70518-3063-67051830630630 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-6) 2022-08-040000-00-00NoNoCurrent