FDA.reportPublic FDA data

Potassium Citrate

Product NDC
68084-850
11-digit product format
680840850
Labeler code
68084
Product ID
68084-850_213c9f49-5d37-f84f-e063-6394a90aa698
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203546
Marketing category
ANDA
Marketing start
2014-11-12
Substance
POTASSIUM CITRATE
Active strength
10 meq/1
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
Potassium Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE10 meq/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEE90ONI6FF
Rxcui199381

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-850-32Potassium Citrate20 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE206
68084-850-33Potassium Citrate1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-850-32EA - Each68084-8502d5ade25-88ae-4904-961a-35ed3819ae1c12014-11-05
68084-850-33EA - Each68084-850eed1def1-0d4f-4297-91da-f495abad7c9d12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM CITRATEACTIVE INGREDIENTEE90ONI6FFPOTASSIUM CITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLPOTASSIUM CITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPOTASSIUM CITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30POTASSIUM CITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-850POTASSIUM CITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20240905_1201c777-2388-4235-bb8f-eb7dc1e867f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN1201c777-2388-4235-bb8f-eb7dc1e867f86
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD1201c777-2388-4235-bb8f-eb7dc1e867f86
199381K+ citrate 10 MEQ Extended Release Oral TabletSY1201c777-2388-4235-bb8f-eb7dc1e867f86
199381Pot citrate 10 MEQ Extended Release Oral TabletSY1201c777-2388-4235-bb8f-eb7dc1e867f86
199381potassium citrate 1080 MG Extended Release Oral TabletSY1201c777-2388-4235-bb8f-eb7dc1e867f86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-850-326808408503220 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-850-32) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-850-33) 20 blister pack2014-11-120000-00-00NoNoCurrent
68084-850-33680840850331 in 1 BLISTER PACKHistorical