NDC 68727-400-01 - Cystadane

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: 68727-400
Requested NDC: 68727-400-01
Package NDCs from labels: 68727-400-01
Manufacturer: Jazz Pharmaceuticals, Inc.
Effective date: 2007-03-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Cystadane® (betaine anhydrous for oral solution)	Jazz Pharmaceuticals, Inc.	2007-03-31	Human prescription drug label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68727-400-01	Cystadane	180 g in 1 BOTTLE	POWDER, FOR SOLUTION	180		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68727-400	CYSTADANE (BETAINE, ANHYDROUS) POWDER, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.]	1	1 package rows	20070517_05964DAE-8B84-467C-AF97-C82706A3CAD2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
betaine, anhydrous	ACTIVE INGREDIENT	3SCV180C9W	CYSTADANE (BETAINE, ANHYDROUS) POWDER, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.]	1
betaine, anhydrous	ACTIVE MOIETY	3SCV180C9W	CYSTADANE (BETAINE, ANHYDROUS) POWDER, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.]	1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betaine	BETAINE	Cosette Pharmaceuticals, Inc.	99b667fa-b00c-465b-bbed-36f317078115	2026-05-20	Warnings, Adverse reactions	Exact identifier rxcui: 562847
Cystadane	BETAINE	Recordati Rare Diseases	31a684d0-cd98-4e46-b43a-ccbd17c41559	2026-04-24	Warnings, Adverse reactions	Exact identifier rxcui: 404539 rxcui: 562847
Betaine Anhydrous	BETAINE ANHYDROUS	Eton Pharmaceuticals, Inc.	ee8a95c3-df9f-6e55-e053-2a95a90ab17b	2023-02-02	Warnings, Adverse reactions	Exact identifier rxcui: 562847
7D587A24-732D-934E-FCA3-381D68D37BBC			05964DAE-8B84-467C-AF97-C82706A3CAD2	2007-03-31	Adverse reactions	Exact identifier spl id: 7D587A24-732D-934E-FCA3-381D68D37BBC spl set id: 05964DAE-8B84-467C-AF97-C82706A3CAD2

Reported adverse events (FAERS/openFDA)#

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