Cystadane

Product NDC
52276-401
11-digit product format
522760401
Labeler code
52276
Product ID
52276-401_66ab8f97-8ea6-dc62-e053-2a91aa0adaf0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
betaine
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Orphan Europe SARL
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2018-01-08
Marketing end
0000-00-00
Substance
BETAINE
Active strength
1 g/g
Pharmacologic classes
Methylating Activity [MoA],Methylating Agent [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52276-401-012022-01-28C16284748780-1d6a99b39-b72a-a426-e053-dadaa90af4c26053d4d2-5967-19e0-e053-2991aa0a819a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52276-401-01Cystadane180 g in 1 BOTTLEPOWDER, FOR SOLUTION1804
52276-401-01Cystadane1 in 1 CARTONPOWDER, FOR SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52276-401-01GM - Gram52276-401cd4ab1d0-2b11-4c83-9daa-659f450d1e0812018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52276-401CYSTADANE (BETAINE) POWDER, FOR SOLUTION [ORPHAN EUROPE SARL]4Legacy NDC, 2 package rows20180305_6053d4d2-5967-19e0-e053-2991aa0a819a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562847betaine anhydrous 1 GM/Scoop Powder for Oral SolutionPSN6053d4d2-5967-19e0-e053-2991aa0a819a4
404539Cystadane 1 GM/Scoop Powder for Oral SolutionPSN6053d4d2-5967-19e0-e053-2991aa0a819a4
404539betaine 1000 MG Powder for Oral Solution [Cystadane]SBD6053d4d2-5967-19e0-e053-2991aa0a819a4
562847betaine 1000 MG Powder for Oral SolutionSCD6053d4d2-5967-19e0-e053-2991aa0a819a4
562847betaine anhydrous 1 GM/Scoop Powder for Oral SolutionSY6053d4d2-5967-19e0-e053-2991aa0a819a4
404539Cystadane 1000 MG (as betaine anhydrous) Powder for Oral SolutionSY6053d4d2-5967-19e0-e053-2991aa0a819a4
404539Cystadane 1000 MG Powder for Oral SolutionSY6053d4d2-5967-19e0-e053-2991aa0a819a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52276-401-0152276040101180 g in 1 BOTTLE180 gHistorical