NDC 68084-850-33 - Potassium Citrate

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
68084-850
Requested NDC
68084-850-33
Package NDCs from labels
68084-850-33, 68084-850-32
Manufacturer
American Health Packaging
Effective date
2024-09-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Potassium Citrate - American Health PackagingAmerican Health Packaging2024-09-03HUMAN PRESCRIPTION DRUG LABEL

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 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 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

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 2 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TeethWhitening KitTEETHWHITENING KITJiangxi Dentalbright Technology Co., Ltd.29393313-217a-dc3a-e063-6294a90addb12024-12-20WarningsExact identifier
unii: EE90ONI6FF
Teeth Whitening KitTEETH WHITENING KITJiangxi Dentalbright Technology Co., Ltd0973b73d-5de9-0986-e063-6294a90a59172024-12-20WarningsExact identifier
unii: EE90ONI6FF
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharmace42122f-8087-471f-b0a3-5524bdbd45262024-11-19Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
TRICITRATESPOTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharma2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad2024-11-15Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
Potassium CitratePOTASSIUM CITRATEAmerican Health Packaging1201c777-2388-4235-bb8f-eb7dc1e867f82024-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA203546
ndc (package): 68084-850-33
ndc (package): 68084-850-32
ndc (product): 68084-850
ndc11 (package): 68084085033
rxcui: 199381
spl id: 213c9f49-5d37-f84f-e063-6394a90aa698
spl set id: 1201c777-2388-4235-bb8f-eb7dc1e867f8
unii: EE90ONI6FF
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepackf2ab3c2e-2a6e-4698-afad-260bdf0d259e2024-08-06Warnings, Adverse reactionsExact identifier
rxcui: 898490
unii: EE90ONI6FF
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepack9774b7c5-4695-47c9-9eb8-e0af2e05f5c32024-05-20Warnings, Adverse reactionsExact identifier
rxcui: 199381
unii: EE90ONI6FF
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepack4af19ffc-80e1-4182-bccf-e7abb1bf457c2024-01-11Warnings, Adverse reactionsExact identifier
rxcui: 199381
unii: EE90ONI6FF
Potassium CitratePOTASSIUM CITRATEGolden State Medical Supply, Inc.cb09c63d-f3f0-5d6b-e053-2995a90acd442023-10-31Warnings, Adverse reactionsExact identifier
application number: ANDA203546
rxcui: 199381
rxcui: 898490
rxcui: 199376
unii: EE90ONI6FF
Potassium CitratePOTASSIUM CITRATEZydus Lifesciences Limited39f46084-fc4b-4bfc-91cb-9be7e647655a2023-10-03Warnings, Adverse reactionsExact identifier
application number: ANDA203546
rxcui: 199381
rxcui: 898490
rxcui: 199376
unii: EE90ONI6FF
Potassium CitratePOTASSIUM CITRATEZydus Pharmaceuticals (USA) Inc.1a839f91-9bbd-4f46-b350-c5e8074b5db72023-10-03Warnings, Adverse reactionsExact identifier
application number: ANDA203546
ndc (product): 68382-537
rxcui: 199381
rxcui: 898490
rxcui: 199376
spl id: b0382b88-fcc4-44de-b66d-a93dabc596f8
spl set id: 1a839f91-9bbd-4f46-b350-c5e8074b5db7
unii: EE90ONI6FF
POTASSIUM CITRATEPOTASSIUM CITRATEBryant Ranch Prepackb977c77b-c212-408e-adac-61736e5ed3622023-09-18Warnings, Adverse reactionsExact identifier
rxcui: 199376
unii: EE90ONI6FF
POTASSIUM CITRATEPOTASSIUM CITRATEBryant Ranch Prepackd2e6ef87-f5d7-409a-91ed-ff0a4763c3bd2023-09-15Warnings, Adverse reactionsExact identifier
rxcui: 199381
unii: EE90ONI6FF
Kali CitricumKALI CITRICUMHahnemann Laboratories, INC.f2fb0248-1fca-2b8b-e053-2995a90a5afa2023-01-23Exact identifier
unii: EE90ONI6FF
Potassium CitratePOTASSIUM CITRATEActavis Pharma, Inc.ac173781-486b-461c-97ae-8b5c69e207922022-06-01Warnings, Adverse reactionsExact identifier
rxcui: 199381
rxcui: 898490
rxcui: 199376
unii: EE90ONI6FF
POTASSIUM CITRATEPOTASSIUM CITRATEXLCare Pharmaceuticals, Inc.360a1012-4bdb-473a-8f1f-4550d3b513432022-01-21Warnings, Adverse reactionsExact identifier
rxcui: 199381
rxcui: 898490
rxcui: 199376
unii: EE90ONI6FF
POTASSIUM CITRATEPOTASSIUM CITRATECamber Pharmaceuticals, Incea933654-e8d2-4662-9a9a-4a6d79a9fb202022-01-19Warnings, Adverse reactionsExact identifier
rxcui: 199381
rxcui: 898490
rxcui: 199376
unii: EE90ONI6FF
UROCIT-KPOTASSIUM CITRATEMission Pharmacal Company72cdea1b-2240-41db-987d-86d5c6aaa9782021-12-02Warnings, Adverse reactionsExact identifier
rxcui: 199381
rxcui: 898490
rxcui: 199376
unii: EE90ONI6FF

Reported adverse events (FAERS/openFDA)#

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