Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension

Product NDC: 68788-7787
11-digit product format: 687887787
Labeler code: 68788
Product ID: 68788-7787_c5bbee8b-5814-48bc-b46c-254fd3852b05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: neomycin and polymyxin B sulfates and hydrocortisone otic
Dosage form: SUSPENSION
Route: AURICULAR (OTIC)
Labeler: Preferred Pharmaceuticals, Inc.
Application: NDA060613
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-10-21
Substance: HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N060613-001	CASPORYN HC	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N060613-001	AT

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N060613-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N060613-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N060613-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N060613-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N060613-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N060613-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N060613-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N060613-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N060613-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N060613-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N060613-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N060613-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N060613-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N060613-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N060613-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N060613-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N060613-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N060613-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N060613-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N060613-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N060613-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N060613-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N060613-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N060613-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N060613-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N060613-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N060613-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N060613-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N060613-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N060613-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N060613-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N060613-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N060613-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N060613-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N060613-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N060613-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N060613-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N060613-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N060613-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N060613-001	AT	1	`f41ea6bd6efb…`

Additional Listing Data#

Finished product: Yes
Brand name base: Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	10 mg/mL
NEOMYCIN SULFATE	3.5 mg/mL
POLYMYXIN B SULFATE	10000 [USP'U]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WI4X0X7BPJ	Internal UNII lookup
057Y626693	Internal UNII lookup
19371312D4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310687	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
5f17fae0-c6ea-452e-b84f-066caf2a95fc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-7787-1	Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	10 mL in 1 BOTTLE	SUSPENSION	10		6
68788-7787-1	Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	1 in 1 CARTON	SUSPENSION	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7787	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION (NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC) SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240724_5f17fae0-c6ea-452e-b84f-066caf2a95fc.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC	Preferred Pharmaceuticals, Inc.	5f17fae0-c6ea-452e-b84f-066caf2a95fc	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 060613 application number: NDA060613 ndc (product): 68788-7787
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC	Rising Pharma Holdings, Inc.	35768adc-b578-4c2e-b461-22de3135a789	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 060613 application number: NDA060613
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC	A-S Medication Solutions	c895676f-446a-4a93-a3d2-addcce96b108	2023-01-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 060613 application number: NDA060613

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310687	hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic Suspension	PSN	5f17fae0-c6ea-452e-b84f-066caf2a95fc	6
310687	hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic Suspension	SCD	5f17fae0-c6ea-452e-b84f-066caf2a95fc	6
310687	hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic Suspension	SY	5f17fae0-c6ea-452e-b84f-066caf2a95fc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7787-1	68788778701	1 BOTTLE in 1 CARTON (68788-7787-1) / 10 mL in 1 BOTTLE	1 bottle	2020-10-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	Preferred Pharmaceuticals, Inc.	2026-08-04	HUMAN PRESCRIPTION DRUG LABEL	7