FDA.reportPublic FDA data

Ciprofloxacin and Dexamethasone

Product NDC
0781-6186
11-digit product format
007816186
Labeler code
0781
Product ID
0781-6186_39a8b845-aa32-4c9d-bef8-18cea1ef7bc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin and dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Sandoz Inc
Application
NDA021537
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-08-10
Substance
CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
Active strength
3; 1 mg/mL; mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021537-001CIPRODEXCIPROFLOXACIN; DEXAMETHASONE0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021537-001AB

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-1884e616aacf4f…
2026-08-18 06:07:402026-07N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICRLD, RS2003-07-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICRLD, RS2003-07-183f01610625f2…
2019-09-15 20:21 UTC2019-09N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICRLD, RS2003-07-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICRLD, RS2003-07-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021537-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N021537-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021537-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021537-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021537-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021537-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021537-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021537-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021537-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021537-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021537-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021537-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021537-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021537-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021537-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021537-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021537-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021537-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N021537-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021537-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021537-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021537-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021537-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021537-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021537-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021537-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021537-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021537-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021537-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021537-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021537-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021537-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021537-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021537-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021537-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021537-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021537-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021537-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021537-00188466502025-06-04U-1578Drug product2014-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N021537-00188466502025-06-04U-1578Drug product2014-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021537-00188466502025-06-04U-1578Drug product2014-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021537-00188466502025-06-04U-1578Drug product2014-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021537-00188466502025-06-04U-1578Drug product2014-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021537-00188466502025-06-04U-1578Drug product2014-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021537-00188466502025-06-04U-1578Drug product2014-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021537-00188466502025-06-04U-1578Drug product2014-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021537-00188466502025-06-04U-1578Drug product2014-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021537-00188466502025-06-04U-1578Drug product2014-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021537-00188466502025-06-04U-1578Drug product2014-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021537-00188466502025-06-04U-1578Drug product2014-10-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021537-00188466502025-06-04U-1578Drug product2014-10-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-00191494862022-09-13U-1578Drug product2015-11-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-00193457142022-09-13U-1578Drug product2016-06-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-00194028052022-09-13U-1578Drug product2016-08-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-00194028052022-09-13U-1679Drug product2016-08-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-00188466502025-06-04U-1578Drug product2014-10-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021537-00191494862022-09-13U-1578Drug product2015-11-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021537-00193457142022-09-13U-1578Drug product2016-06-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021537-00194028052022-09-13U-1578Drug product2016-08-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021537-00194028052022-09-13U-1679Drug product2016-08-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021537-00188466502025-06-04U-1578Drug product2014-10-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021537-00191494862022-09-13U-1578Drug product2015-11-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021537-00193457142022-09-13U-1578Drug product2016-06-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021537-00194028052022-09-13U-1578Drug product2016-08-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021537-00194028052022-09-13U-1679Drug product2016-08-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021537-00188466502025-06-04U-1578Drug product2014-10-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021537-00162848042020-08-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021537-00163590162020-08-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021537-00191494862022-09-13U-1578Drug product2015-11-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021537-00193457142022-09-13U-1578Drug product2016-06-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021537-00194028052022-09-13U-1578Drug product2016-08-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021537-00194028052022-09-13U-1679Drug product2016-08-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021537-00188466502025-06-04U-1578Drug product2014-10-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021537-00191494862022-09-13U-1578Drug product2015-11-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021537-00193457142022-09-13U-1578Drug product2016-06-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021537-00194028052022-09-13U-1679Drug product2016-08-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021537-00194028052022-09-13U-1578Drug product2016-08-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021537-00188466502025-06-04U-1578Drug product2014-10-03bb7c543d1eb4…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin and Dexamethasone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE3 mg/mL
DEXAMETHASONE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4BA73M5E37Internal UNII lookup
7S5I7G3JQLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
403908Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89fef4d2-7078-47f1-96bf-aca50b135a97Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-6186-67Ciprofloxacin and Dexamethasone7.5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS7.54
0781-6186-67Ciprofloxacin and Dexamethasone1 in 1 CARTONSUSPENSION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-6186-67ML - Milliliter0781-6186b11a18a6-e91c-4aca-94be-100ee46eeac412020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-6186CIPROFLOXACIN AND DEXAMETHASONE SUSPENSION/ DROPS [SANDOZ INC]4Current NDC, Legacy NDC, 2 package rows20250502_89fef4d2-7078-47f1-96bf-aca50b135a97.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONESandoz Inc89fef4d2-7078-47f1-96bf-aca50b135a972025-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 021537
application number: NDA021537
ndc (product): 0781-6186

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403908ciprofloxacin 0.3 % / dexAMETHasone 0.1 % Otic SuspensionPSN89fef4d2-7078-47f1-96bf-aca50b135a974
403908ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSCD89fef4d2-7078-47f1-96bf-aca50b135a974
403908ciprofloxacin (as ciprofloxacin hydrochloride) 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSY89fef4d2-7078-47f1-96bf-aca50b135a974
403908ciprofloxacin 0.3 % / dexamethasone 0.1 % Otic SuspensionSY89fef4d2-7078-47f1-96bf-aca50b135a974
403908ciprofloxacin 0.3 % / dexAMETHasone 0.1 % Otic SuspensionPSN1d878e17-8c2c-2ce2-e063-6294a90a87371
403908ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSCD1d878e17-8c2c-2ce2-e063-6294a90a87371
403908ciprofloxacin (as ciprofloxacin hydrochloride) 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSY1d878e17-8c2c-2ce2-e063-6294a90a87371
403908ciprofloxacin 0.3 % / dexamethasone 0.1 % Otic SuspensionSY1d878e17-8c2c-2ce2-e063-6294a90a87371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-6186-67007816186671 BOTTLE, DROPPER in 1 CARTON (0781-6186-67) / 7.5 mL in 1 BOTTLE, DROPPER2020-08-100000-00-00NoNoCurrent