ciprofloxacin

Product NDC
33261-399
11-digit product format
332610399
Labeler code
33261
Product ID
33261-399_da202d5d-414e-42a2-8a90-e20c90b0afec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076639
Marketing category
ANDA
Marketing start
2004-09-10
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-399IInactivated by FDA2026-08-10
excluded packagepackage33261-39933261-399-06IInactivated by FDA2026-08-10
excluded packagepackage33261-39933261-399-10IInactivated by FDA2026-08-10
excluded packagepackage33261-39933261-399-14IInactivated by FDA2026-08-10
excluded packagepackage33261-39933261-399-20IInactivated by FDA2026-08-10
excluded packagepackage33261-39933261-399-21IInactivated by FDA2026-08-10
excluded packagepackage33261-39933261-399-30IInactivated by FDA2026-08-10

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 3 · 147 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-399-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-399-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-399-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-399-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-399-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-399-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-399-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-399-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-399-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-399-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-399-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-399-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-399-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-399-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-399-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-399-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-399-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-399-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-399-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-399-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-399-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-399-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-399-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-399-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-399-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-399-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-399-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-399-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-399-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-399-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-399-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-399-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-399-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-399-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-399-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-399-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-399-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-399-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-399-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-399-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-399-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-399-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-399-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-399-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-399-21ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-399-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-399-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-399-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-399-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-399-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-399-210efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076639-001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10
A076639-002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10
A076639-003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076639-001AB
A076639-002AB
A076639-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-108072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076639-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076639-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076639-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076639-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076639-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076639-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076639-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076639-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076639-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076639-001AB18072bd15b7f6…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-399-06ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET63
33261-399-10ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET103
33261-399-14ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET143
33261-399-20ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET203
33261-399-21ciprofloxacin21 in 1 BOTTLE, PLASTICTABLET213
33261-399-30ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-399-06EA - Each33261-3999ca5311c-c742-4103-9d27-833da4181bce12015-10-02
33261-399-10EA - Each33261-399877d44ac-be31-4a25-90a9-e1e638b85a1012015-10-02
33261-399-14EA - Each33261-3990193678b-1c9d-4f40-943f-185ef890c2f412015-10-02
33261-399-20EA - Each33261-399c231e7f5-667c-4704-ba05-eef8b3c9afd712015-10-02
33261-399-21EA - Each33261-39900a65da0-20ab-4b71-902c-99dd4f12c9e112016-09-02
33261-399-30EA - Each33261-3991811b485-1b72-47cc-99e8-f2188a148d1a12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-399CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 6 package rows20140102_d10f7c93-a08b-4e9c-bfa2-6646e3ea21bd.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 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ciprofloxacinCIPROFLOXACINNorthwind Health Company, LLC4deea61e-f3ca-b35d-e063-6294a90a9d412026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINCardinal Health 107, LLC922e9f5c-cc59-4d9e-bf42-a4b900d077ed2026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINMajor Pharmaceuticalsf818ed31-c746-4171-afdf-57a75434e5f12026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINQPharma, Inc.4149d980-a6cd-c06d-e063-6394a90a47a12025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINRising Pharma Holdings, Inc.ef468722-68cd-440b-afd7-2285029db41f2025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.2491e6a9-3415-43b9-b31b-67331f52806a2025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.e81341c6-0e25-4860-adda-2d3cebe88d622025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.178dc379-e2b8-4b47-9f0c-3fc7fb435c362025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINA-S Medication Solutionsc12b316f-811c-48b6-a320-d314991aa74f2025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINBryant Ranch Prepack69df48cc-76b6-428e-891a-c25e07d785f82025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINBryant Ranch Prepacka5ecc693-b8fd-4a7a-8040-e56f801c93532025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINCoupler LLC2fff7a38-2c4e-d343-e063-6294a90aca3c2025-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINUmasuto, LLC0c355077-7361-41d0-9e82-eb31beaf5daa2025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals, Inc.44e5582d-fff1-0ec9-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals, Inc.46dedf2c-26de-0f46-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.641729a3-6dd3-3a2f-e053-2991aa0a015e2024-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.5bab9397-b9f3-d309-e053-2991aa0a66122024-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINA-S Medication Solutions6971a958-08f0-4712-bf5f-47fe4f76b8632023-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPharmPak, Inc.e2902d14-16bb-46a9-a45a-4f1f9b0ecf4a2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPharmPak, Inc.6a70db6c-ae68-49e5-8a4a-b5cd1d4840bd2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
309309ciprofloxacin 500 MG Oral TabletPSNd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
197512ciprofloxacin 750 MG Oral TabletPSNd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
197511ciprofloxacin 250 MG Oral TabletSCDd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
309309ciprofloxacin 500 MG Oral TabletSCDd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
197512ciprofloxacin 750 MG Oral TabletSCDd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSYd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-399-06332610399066 in 1 BOTTLE, PLASTICHistorical
33261-399-103326103991010 in 1 BOTTLE, PLASTICHistorical
33261-399-143326103991414 in 1 BOTTLE, PLASTICHistorical
33261-399-203326103992020 in 1 BOTTLE, PLASTICHistorical
33261-399-213326103992121 in 1 BOTTLE, PLASTICHistorical
33261-399-303326103993030 in 1 BOTTLE, PLASTICHistorical