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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage81943-701-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage81943-701-01367a005e9d99…383a685ebd0f…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2968PHW8QPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
040713e7-67cd-8eb0-e063-6394a90aa2a9Available on FDA.report

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CITRACID-50DESINFECTANT SOLUTION FOR HEMODIALYSIS MACHINEAqua Medica, S.A. de C.V.040713e7-67cd-8eb0-e063-6394a90aa2a92025-11-10WarningsExact identifier
ndc (product): 81943-701

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 ml2023-03-30NoNoCurrent