NDC 59630-309-01 - Doribax

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: 59630-309
Requested NDC: 59630-309-01
Package NDCs from labels: 59630-309-01, 59630-309-10
Manufacturer: Shionogi Inc. | Shionogi Pharma Co., Ltd.
Effective date: 2019-05-13
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Doribax - Shionogi Inc. \| Shionogi Pharma Co., Ltd.	Shionogi Inc. \| Shionogi Pharma Co., Ltd.	2019-05-13	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59630-309-01	EA - Each	59630-309	92cc41de-b248-4082-a824-8e764e4844cd	1	2013-10-17
59630-309-10	EA - Each	59630-309	bc5af5c2-f493-48de-b8b9-2a0455ea6d38	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
DORIPENEM	ACTIVE INGREDIENT	BHV525JOBH	DORIBAX (DORIPENEM) POWDER, FOR SOLUTION [SHIONOGI INC.]	8
DORIPENEM	ACTIVE MOIETY	BHV525JOBH	DORIBAX (DORIPENEM) POWDER, FOR SOLUTION [SHIONOGI INC.]	8

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8879a2d9-9310-b59a-e053-2a95a90ab1c2			974cac49-7d08-4c2a-9c24-ce75f66d9d75	2019-05-13	Warnings, Adverse reactions	Exact identifier spl id: 8879a2d9-9310-b59a-e053-2a95a90ab1c2 spl set id: 974cac49-7d08-4c2a-9c24-ce75f66d9d75

Reported adverse events (FAERS/openFDA)#

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