CASPORYN HC

Product NDC: 70199-011
11-digit product format: 701990011
Labeler code: 70199
Product ID: 70199-011_26e37e84-0edd-410d-be1a-2bf71d2fe133
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: neomycin and polymyxin B sulfates and hydrocortisone otic
Dosage form: SUSPENSION
Route: AURICULAR (OTIC)
Labeler: Casper Pharma LLC
Application: NDA060613
Marketing category: NDA
Marketing start: 2019-03-15
Marketing end: 0000-00-00
Substance: HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 10 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70199-011		D	Discontinued by firm		2026-07-31
excluded package	package	70199-011	70199-011-10	D	Discontinued by firm		2026-07-31

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

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, RS, 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982		`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N060613-001	AT	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	2025-08-19	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	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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70199-011	CASPORYN HC (NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC) SUSPENSION [CASPER PHARMA LLC]	6	Legacy NDC	20240606_14bb3363-1b52-4596-afcc-47457b064217.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70199-011-10	70199001110	1 BOTTLE in 1 CARTON (70199-011-10) > 10 mL in 1 BOTTLE	1 bottle	2019-03-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CASPORYN HC (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Sterile	Casper Pharma LLC \| Eugia Pharma Specialities Limited	2024-06-03	Human Prescription Drug Label	6