NDC 49427-247-11 - ReBalance Antiprotozoal

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: 49427-247
Requested NDC: 49427-247-11
Package NDCs from labels: 49427-247-11
Manufacturer: Pegasus Laboratories, Inc
Effective date: 2023-12-21
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ReBalance Antiprotozoal - Pegasus Laboratories, Inc	Pegasus Laboratories, Inc	2023-12-21	PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49427-247-11	ReBalance Antiprotozoal	12 in 1 CARTON	SUSPENSION	12		7
49427-247-11	ReBalance Antiprotozoal	946 mL in 1 BOTTLE	SUSPENSION	946		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49427-247	REBALANCE ANTIPROTOZOAL (SULFADIAZINE AND PYRIMETHAMINE) SUSPENSION [PEGASUS LABORATORIES, INC]	7	2 package rows	20231222_25ddc8fa-3f23-4786-af2f-db8135d73b09.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Pyrimethamine	ACTIVE INGREDIENT	Z3614QOX8W	REBALANCE ANTIPROTOZOAL (SULFADIAZINE AND PYRIMETHAMINE) SUSPENSION [PRN PHARMACAL]	2
SULFADIAZINE SODIUM	ACTIVE INGREDIENT	84CS1P306F	REBALANCE ANTIPROTOZOAL (SULFADIAZINE AND PYRIMETHAMINE) SUSPENSION [PRN PHARMACAL]	2
Pyrimethamine	ACTIVE MOIETY	Z3614QOX8W	REBALANCE ANTIPROTOZOAL (SULFADIAZINE AND PYRIMETHAMINE) SUSPENSION [PRN PHARMACAL]	2
Sulfadiazine	ACTIVE MOIETY	0N7609K889	REBALANCE ANTIPROTOZOAL (SULFADIAZINE AND PYRIMETHAMINE) SUSPENSION [PRN PHARMACAL]	2

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pyrimethamine	PYRIMETHAMINE	Aurobindo Pharma Limited	7aca002e-a538-4715-9121-a17bdb7f200c	2024-01-19	Warnings, Adverse reactions	Exact identifier unii: Z3614QOX8W
Daraprim	PYRIMETHAMINE	TILDE Sciences LLC	f634f34b-0952-4dd3-9da3-f84b6ab823de	2023-12-07	Warnings, Adverse reactions	Exact identifier unii: Z3614QOX8W
Pyrimethamine	PYRIMETHAMINE	DR.REDDYS LABORATORIES INC	b82d019d-c235-4b38-a097-6fe3e6fc8461	2023-03-20	Warnings, Adverse reactions	Exact identifier unii: Z3614QOX8W
Daraprim	PYRIMETHAMINE	Vyera Pharmaceuticals LLC	5368616d-6520-6f6e-2053-686b72656c69	2021-11-11	Warnings, Adverse reactions	Exact identifier unii: Z3614QOX8W
Pyrimethamine	PYRIMETHAMINE	OAKRUM PHARMA, LLC	8ed8141b-e6c0-4a6b-8a08-2858c8c8bd4a	2021-11-11	Warnings, Adverse reactions	Exact identifier unii: Z3614QOX8W
Pyrimethamine	PYRIMETHAMINE	Teva Pharmaceuticals, Inc.	2c57a992-619b-40ce-9395-f12ac47a2c67	2021-08-19	Warnings, Adverse reactions	Exact identifier unii: Z3614QOX8W

Reported adverse events (FAERS/openFDA)#

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