FDA.reportPublic FDA data

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

Product NDC
61919-662
Requested package NDC
61919-662-10
11-digit product format
619190662
Labeler code
61919
Product ID
61919-662_9caacf41-212b-b2f3-e053-2a95a90aee1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Dosage form
SUSPENSION/ DROPS
Route
AURICULAR (OTIC)
Labeler
DIRECT RX
Application
ANDA064065
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
10 mg/mL; mg/mL; [USP'U]/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-66261919-662-10IInactivated by FDA2026-10-05

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A064065-001OTICAIRHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICATRS1996-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064065-001AT

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 22:38:342026-08A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICATRS1996-08-2884e616aacf4f…
2026-08-18 06:07:402026-07A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-283f01610625f2…
2019-09-15 20:21 UTC2019-09A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064065-001OTICAIR1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICAT1996-08-28f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A064065-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A064065-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064065-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064065-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064065-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064065-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064065-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064065-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064065-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064065-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064065-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064065-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064065-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064065-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064065-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064065-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064065-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064065-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064065-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064065-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064065-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064065-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064065-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064065-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064065-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064065-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064065-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064065-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064065-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064065-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064065-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064065-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064065-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064065-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064065-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064065-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064065-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064065-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064065-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064065-001AT1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-662-102023-01-30C16284748780-1f386c649-f897-0266-e053-dadaa90a7c1aNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-662-10NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE10 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-662-10ML - Milliliter61919-6625c9d3c14-a02c-4859-ba54-4abb5e2300c312015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
THIMEROSALINACTIVE INGREDIENT2225PI3MOVNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
WATERINACTIVE INGREDIENT059QF0KO0RNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-662NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]3Legacy NDC, 1 package rows20200130_cb105db7-ab14-4b10-8a19-58bcb5eb27cd.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEPreferred Pharmaceuticals, Inc.f8dc2b6f-daf3-4a3a-b31f-b97e2f152eae2026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064065
application number: ANDA064065
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEA-S Medication Solutions1185a82b-e731-456a-8fc1-d9f0fc1ab0bc2026-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064065
application number: ANDA064065
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEBausch & Lomb Incorporatedb0ee85dd-5fe1-46a3-9bff-606e489d20b12025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064065
application number: ANDA064065
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONENuCare Pharmaceuticals,Inc.6296e2ed-336b-b9af-e053-2991aa0aae0c2024-11-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064065
application number: ANDA064065
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LP98042cef-2839-49d6-a7bd-a1d29c74430b2022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064065
application number: ANDA064065

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310687hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic SuspensionPSNcb105db7-ab14-4b10-8a19-58bcb5eb27cd3
310687hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SuspensionSCDcb105db7-ab14-4b10-8a19-58bcb5eb27cd3
310687hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic SuspensionSYcb105db7-ab14-4b10-8a19-58bcb5eb27cd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-662-106191906621010 mL in 1 BOTTLE, DROPPER (61919-662-10) 10 ml2014-01-010000-00-00NoNoCurrent