Potassium Citrate

Product NDC
65841-538
11-digit product format
658410538
Labeler code
65841
Product ID
65841-538_042721ed-7f5d-47f1-beff-b54ba88bcd27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA203546
Marketing category
ANDA
Marketing start
2014-08-12
Substance
POTASSIUM CITRATE
Active strength
15 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 CITRATE15 meq/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEE90ONI6FF
Rxcui199376, 199381, 898490

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
65841-538-01Potassium Citrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
65841-538-05Potassium Citrate500 in 1 BOTTLETABLET, EXTENDED RELEASE5005
65841-538-06Potassium Citrate30 in 1 BOTTLETABLET, EXTENDED RELEASE305
65841-538-10Potassium Citrate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10005
65841-538-16Potassium Citrate90 in 1 BOTTLETABLET, EXTENDED RELEASE905
65841-538-30Potassium Citrate10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE105
65841-538-30Potassium Citrate10 in 1 CARTONTABLET, EXTENDED RELEASE105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-538POTASSIUM CITRATE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 7 package rows20231004_39f46084-fc4b-4bfc-91cb-9be7e647655a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN39f46084-fc4b-4bfc-91cb-9be7e647655a5
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN39f46084-fc4b-4bfc-91cb-9be7e647655a5
199376potassium citrate 5 MEQ Extended Release Oral TabletPSN39f46084-fc4b-4bfc-91cb-9be7e647655a5
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD39f46084-fc4b-4bfc-91cb-9be7e647655a5
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD39f46084-fc4b-4bfc-91cb-9be7e647655a5
199376potassium citrate 5 MEQ Extended Release Oral TabletSCD39f46084-fc4b-4bfc-91cb-9be7e647655a5
199381K+ citrate 10 MEQ Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
898490K+ citrate 15 MEQ Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
199376K+ citrate 5 MEQ Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
199381Pot citrate 10 MEQ Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
898490Pot citrate 15 MEQ Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
199376Pot citrate 5 MEQ Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
199381potassium citrate 1080 MG Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
898490potassium citrate 1620 MG Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5
199376potassium citrate 540 MG Extended Release Oral TabletSY39f46084-fc4b-4bfc-91cb-9be7e647655a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-538-0165841053801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-538-01) 2014-08-120000-00-00NoNoCurrent
65841-538-0565841053805500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-538-05) 2014-08-120000-00-00NoNoCurrent
65841-538-066584105380630 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-538-06) 2014-08-120000-00-00NoNoCurrent
65841-538-10658410538101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-538-10) 2014-08-120000-00-00NoNoCurrent
65841-538-166584105381690 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-538-16) 2014-08-120000-00-00NoNoCurrent
65841-538-306584105383010 BLISTER PACK in 1 CARTON (65841-538-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2014-08-120000-00-00NoNoCurrent