NDC 13985-566 - GenOne

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 13985-566
Package NDCs from labels: 13985-566-60, 13985-566-12, 13985-566-24
Manufacturer: MWI | FIRST PRIORITY INCORPORATED
Effective date: 2023-09-26
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
GenOne - MWI \| FIRST PRIORITY INCORPORATED	MWI \| FIRST PRIORITY INCORPORATED	2023-09-26	PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13985-566-12	GenOne	120 mL in 1 BOTTLE, SPRAY	SPRAY	120	7
13985-566-12	GenOne	12 in 1 CASE	SPRAY	12	7
13985-566-24	GenOne	240 mL in 1 BOTTLE, SPRAY	SPRAY	240	7
13985-566-24	GenOne	12 in 1 CASE	SPRAY	12	7
13985-566-60	GenOne	60 mL in 1 BOTTLE, SPRAY	SPRAY	60	7
13985-566-60	GenOne	12 in 1 CASE	SPRAY	12	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13985-566	GENONE (GENTAMICIN SULFATE) SPRAY [MWI]	7	6 package rows	20230927_83e23b7f-9007-487f-b519-65fb4707fbbc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BETAMETHASONE VALERATE	ACTIVE INGREDIENT	9IFA5XM7R2	GENONE (GENTAMICIN SULFATE) SPRAY [MWI]	5
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	GENONE (GENTAMICIN SULFATE) SPRAY [MWI]	5
BETAMETHASONE	ACTIVE MOIETY	9842X06Q6M	GENONE (GENTAMICIN SULFATE) SPRAY [MWI]	5
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	GENONE (GENTAMICIN SULFATE) SPRAY [MWI]	5

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 2 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	63413469-c676-48a3-a945-7d2489b535ef	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 8X7386QRLV
Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	84f5c763-1cd3-4d85-9afb-934db8666fbf	2024-10-11	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 8X7386QRLV
Betamethasone valerate	BETAMETHASONE VALERATE	Alembic Pharmaceuticals Inc.	3b6fa573-de04-4626-a39a-dca39def6df2	2024-08-23	Adverse reactions	Exact identifier unii: 9IFA5XM7R2
Gentamicin Sulfate	GENTAMICIN SULFATE	NuCare Pharmaceuticals, Inc.	4add8f7b-48f0-6b6a-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Exact identifier unii: 8X7386QRLV
Gentamicin Sulfate	GENTAMICIN SULFATE	Bausch & Lomb Incorporated	41d01350-5c4b-42fc-be5f-986ceec02bd3	2024-07-22	Warnings, Adverse reactions	Exact identifier unii: 8X7386QRLV
Betamethasone Valerate	BETAMETHASONE VALERATE	NuCare Pharmaceuticals,Inc.	a2154b33-0f61-49af-e053-2995a90a1810	2024-06-20	Adverse reactions	Exact identifier unii: 9IFA5XM7R2
Gentamicin Sulfate	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	82595309-304e-a221-e053-2991aa0ac0a9	2024-06-14	Warnings, Adverse reactions	Exact identifier unii: 8X7386QRLV
GENTAMICIN SULFATE	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	85424b40-5c2d-421d-e053-2991aa0a7771	2024-06-14	Warnings, Adverse reactions	Exact identifier unii: 8X7386QRLV
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	NuCare Pharmaceuticals,Inc.	64badc1a-8922-c6e3-e053-2991aa0a8b1c	2024-06-06	Adverse reactions	Exact identifier unii: 9IFA5XM7R2
Betamethasone Valerate	BETAMETHASONE VALERATE	Padagis Israel Pharmaceuticals Ltd	dc5dfd3e-7762-40c8-880e-c7db80d87749	2024-03-31	Warnings, Adverse reactions	Exact identifier unii: 9IFA5XM7R2
GENTAMICIN	GENTAMICIN	HF Acquisition Co LLC, DBA HealthFirst	c1ff0cdc-ac5d-30ca-e053-2a95a90a5066	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 8X7386QRLV
GENTAMICIN SULFATE	GENTAMICIN SULFATE	HF Acquisition Co LLC, DBA HealthFirst	e9fbe619-2afe-f1d7-e053-2a95a90aab29	2024-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 8X7386QRLV
Gentamicin Sulfate	GENTAMICIN SULFATE	Padagis Israel Pharmaceuticals Ltd	a9486ae1-350b-41c5-ae0c-a4d692bb2dfd	2024-01-15	Adverse reactions	Exact identifier unii: 8X7386QRLV
gentamicin sulfate	GENTAMICIN SULFATE	DIRECT RX	51a411a0-2671-4c1c-bf25-e29b32efed0c	2024-01-10	Warnings, Adverse reactions	Exact identifier unii: 8X7386QRLV
Gentamicin Sulfate	GENTAMICIN SULFATE	Sandoz Inc	a213fb9c-08ea-4f30-a6c9-93c7a9ba5280	2024-01-02	Warnings, Adverse reactions	Exact identifier unii: 8X7386QRLV
Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	8bdeef7f-ad8e-46e0-a872-e945eae51d68	2023-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 8X7386QRLV
Betamethasone Valerate	BETAMETHASONE VALERATE	A-S Medication Solutions	f8711d17-de6a-45e3-8027-b650308207ed	2023-12-15	Adverse reactions	Exact identifier unii: 9IFA5XM7R2
Betamethasone Valerate	BETAMETHASONE VALERATE	A-S Medication Solutions	d265d143-343f-41ec-9cb4-18d83edb772b	2023-12-12	Adverse reactions	Exact identifier unii: 9IFA5XM7R2
Gentamicin Sulfate	GENTAMICIN SULFATE	Cosette Pharmaceuticals, Inc.	16474069-510b-0754-9d78-9bc0354f6549	2023-11-23	Adverse reactions	Exact identifier unii: 8X7386QRLV
Gentamicin Sulfate	GENTAMICIN SULFATE	Cosette Pharmaceuticals, Inc.	9e550dc9-509e-da05-8a97-ecbd0f5dd633	2023-11-22	Adverse reactions	Exact identifier unii: 8X7386QRLV

Reported adverse events (FAERS/openFDA)#

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