Ciprofloxacin

Product NDC
65862-076
11-digit product format
658620076
Labeler code
65862
Product ID
65862-076_9e7eb1ac-3e09-4b4c-8ce1-ab16c3102a10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077859
Marketing category
ANDA
Marketing start
2007-04-26
Marketing end
2027-01-31
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65862-07665862-076-20DDiscontinued by firm2026-08-17
excluded packagepackage65862-07665862-076-30DDiscontinued by firm2026-08-17
excluded packagepackage65862-07665862-076-99DDiscontinued 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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusArchiveSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipa6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipa6255e0c9aa5…a0211a219f2e…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65862-076-99DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65862-076-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65862-076-20DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65862-076-99DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65862-076-30DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65862-076-20DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip1d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipe30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipe30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipbbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipf268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipf764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip68b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip05c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip48b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip27f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipd1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip50b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip6db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage65862-076-39UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…

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
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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077859-001CIPROFLOXACIN 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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-261e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077859-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077859-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077859-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE250 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
2b3b6a9f-259c-4736-b88f-f49d1eb64286Available 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
65862-076-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED10033
65862-076-20Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED2033
65862-076-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED3033
65862-076-99Ciprofloxacin1000 in 1 BOTTLETABLET, FILM COATED100033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-076-01EA - Each65862-076654d9327-acd7-41e8-8968-dc3cae7f3abe12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-076CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]32Current NDC, Legacy NDC, 4 package rows20250501_2b3b6a9f-259c-4736-b88f-f49d1eb64286.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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 HYDROCHLORIDEREMEDYREPACK INC.47d1e4c5-f669-4aca-9e8c-0d6bb833b8592026-05-12Boxed 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 Solutions4dd69fb7-802a-4278-a730-c722a3ca35212026-05-05Boxed 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN2b3b6a9f-259c-4736-b88f-f49d1eb6428633
309309ciprofloxacin 500 MG Oral TabletPSN2b3b6a9f-259c-4736-b88f-f49d1eb6428633
197512ciprofloxacin 750 MG Oral TabletPSN2b3b6a9f-259c-4736-b88f-f49d1eb6428633
197511ciprofloxacin 250 MG Oral TabletSCD2b3b6a9f-259c-4736-b88f-f49d1eb6428633
309309ciprofloxacin 500 MG Oral TabletSCD2b3b6a9f-259c-4736-b88f-f49d1eb6428633
197512ciprofloxacin 750 MG Oral TabletSCD2b3b6a9f-259c-4736-b88f-f49d1eb6428633
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY2b3b6a9f-259c-4736-b88f-f49d1eb6428633
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY2b3b6a9f-259c-4736-b88f-f49d1eb6428633
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY2b3b6a9f-259c-4736-b88f-f49d1eb6428633
197511ciprofloxacin 250 MG Oral TabletPSN4dd69fb7-802a-4278-a730-c722a3ca352122
197511ciprofloxacin 250 MG Oral TabletSCD4dd69fb7-802a-4278-a730-c722a3ca352122
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY4dd69fb7-802a-4278-a730-c722a3ca352122
197511ciprofloxacin 250 MG Oral TabletPSN686a2ae7-dbc1-ccbf-e053-2991aa0a55254
197511ciprofloxacin 250 MG Oral TabletSCD686a2ae7-dbc1-ccbf-e053-2991aa0a55254
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY686a2ae7-dbc1-ccbf-e053-2991aa0a55254
197511ciprofloxacin 250 MG Oral TabletPSN2f123a2c-3f94-ca2d-e063-6394a90aff683
197511ciprofloxacin 250 MG Oral TabletSCD2f123a2c-3f94-ca2d-e063-6394a90aff683
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY2f123a2c-3f94-ca2d-e063-6394a90aff683
197511ciprofloxacin 250 MG Oral TabletPSN9ee1f252-a64e-4b72-a6f7-60298e8272222
197511ciprofloxacin 250 MG Oral TabletPSNcef015d0-b228-42b3-9b9b-eda2045d15dd2
197511ciprofloxacin 250 MG Oral TabletSCD9ee1f252-a64e-4b72-a6f7-60298e8272222
197511ciprofloxacin 250 MG Oral TabletSCDcef015d0-b228-42b3-9b9b-eda2045d15dd2
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY9ee1f252-a64e-4b72-a6f7-60298e8272222
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYcef015d0-b228-42b3-9b9b-eda2045d15dd2
197511ciprofloxacin 250 MG Oral TabletPSN043e4beb-5dc0-2fdb-e063-6294a90afded1
197511ciprofloxacin 250 MG Oral TabletPSN3ab54ca0-1b12-d0f5-e063-6394a90a95751
197511ciprofloxacin 250 MG Oral TabletSCD3ab54ca0-1b12-d0f5-e063-6394a90a95751
197511ciprofloxacin 250 MG Oral TabletSCD043e4beb-5dc0-2fdb-e063-6294a90afded1
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY3ab54ca0-1b12-d0f5-e063-6394a90a95751
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY043e4beb-5dc0-2fdb-e063-6294a90afded1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-076-0165862007601100 TABLET, FILM COATED in 1 BOTTLE (65862-076-01) 2007-04-262027-01-31NoNoCurrent
65862-076-206586200762020 TABLET, FILM COATED in 1 BOTTLE (65862-076-20) 2007-04-260000-00-00NoNoCurrent
65862-076-306586200763030 TABLET, FILM COATED in 1 BOTTLE (65862-076-30) 2007-04-260000-00-00NoNoCurrent
65862-076-99658620076991000 TABLET, FILM COATED in 1 BOTTLE (65862-076-99) 2007-04-260000-00-00NoNoCurrent