CITRACID-50

Product NDC
81943-701
11-digit product format
819430701
Labeler code
81943
Product ID
81943-701_43486bf7-f87e-f437-e063-6394a90a338c
Type
HUMAN OTC DRUG
Nonproprietary name
Desinfectant Solution for Hemodialysis Machine
Dosage form
SOLUTION, CONCENTRATE
Route
HEMODIALYSIS
Labeler
Aqua Medica, S.A. de C.V.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-03-30
Substance
CITRIC ACID MONOHYDRATE
Active strength
.5 g/100mL
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CITRACID-50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITRIC ACID MONOHYDRATE.5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2968PHW8QP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81943-701-01CITRACID-505000 mL in 1 CONTAINERSOLUTION, CONCENTRATE50003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81943-701CITRACID-50 (DESINFECTANT SOLUTION FOR HEMODIALYSIS MACHINE) SOLUTION, CONCENTRATE [AQUA MEDICA, S.A. DE C.V.]2Current NDC, 1 package rows20241120_040713e7-67cd-8eb0-e063-6394a90aa2a9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81943-701-01819430701015000 mL in 1 CONTAINER (81943-701-01) 5000 ml2023-03-30NoNoHistorical