FDA.reportPublic FDA data

UROCIT-K

Product NDC
0178-0615
11-digit product format
001780615
Labeler code
0178
Product ID
0178-0615_44ffdb97-c338-85b4-e063-6294a90a418a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Mission Pharmacal Company
Application
NDA019071
Marketing category
NDA
Marketing start
2010-01-27
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
UROCIT-K
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE15 meq/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEE90ONI6FF
Rxcui199376, 199381, 603281, 603282, 898490, 898517

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0615-01UROCIT-K100 in 1 BOTTLETABLET, EXTENDED RELEASE10028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0615-01EA - Each0178-0615806f192c-4120-484f-8da2-44536fbe45f412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
potassium citrateACTIVE INGREDIENTEE90ONI6FFUROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [MISSION PHARMACAL COMPANY]2
potassium cationACTIVE MOIETY295O53K152UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [MISSION PHARMACAL COMPANY]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZUROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [MISSION PHARMACAL COMPANY]2
magnesium stearateINACTIVE INGREDIENT70097M6I30UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [MISSION PHARMACAL COMPANY]2
POTASSIUM CITRATEACTIVE INGREDIENTEE90ONI6FFUROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POTASSIUM CATIONACTIVE MOIETY295O53K152UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZUROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0615UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [MISSION PHARMACAL COMPANY]26Current NDC, Legacy NDC, 1 package rows20240529_72cdea1b-2240-41db-987d-86d5c6aaa978.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN72cdea1b-2240-41db-987d-86d5c6aaa97828
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN72cdea1b-2240-41db-987d-86d5c6aaa97828
199376potassium citrate 5 MEQ Extended Release Oral TabletPSN72cdea1b-2240-41db-987d-86d5c6aaa97828
603281UROCIT-K 10 MEQ Extended Release Oral TabletPSN72cdea1b-2240-41db-987d-86d5c6aaa97828
898517UROCIT-K 15 MEQ Extended Release Oral TabletPSN72cdea1b-2240-41db-987d-86d5c6aaa97828
603282UROCIT-K 5 MEQ Extended Release Oral TabletPSN72cdea1b-2240-41db-987d-86d5c6aaa97828
603281potassium citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]SBD72cdea1b-2240-41db-987d-86d5c6aaa97828
898517potassium citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]SBD72cdea1b-2240-41db-987d-86d5c6aaa97828
603282potassium citrate 5 MEQ Extended Release Oral Tablet [Urocit-K]SBD72cdea1b-2240-41db-987d-86d5c6aaa97828
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD72cdea1b-2240-41db-987d-86d5c6aaa97828
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD72cdea1b-2240-41db-987d-86d5c6aaa97828
199376potassium citrate 5 MEQ Extended Release Oral TabletSCD72cdea1b-2240-41db-987d-86d5c6aaa97828
199381K+ citrate 10 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
603281K+ citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]SY72cdea1b-2240-41db-987d-86d5c6aaa97828
898490K+ citrate 15 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
898517K+ citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]SY72cdea1b-2240-41db-987d-86d5c6aaa97828
199376K+ citrate 5 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
603282K+ citrate 5 MEQ Extended Release Oral Tablet [Urocit-K]SY72cdea1b-2240-41db-987d-86d5c6aaa97828
199381Pot citrate 10 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
603281Pot citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]SY72cdea1b-2240-41db-987d-86d5c6aaa97828
898490Pot citrate 15 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
898517Pot citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]SY72cdea1b-2240-41db-987d-86d5c6aaa97828
199376Pot citrate 5 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
603282Pot citrate 5 MEQ Extended Release Oral Tablet [Urocit-K]SY72cdea1b-2240-41db-987d-86d5c6aaa97828
199381potassium citrate 1080 MG Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
898490potassium citrate 1620 MG Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
199376potassium citrate 540 MG Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
603281Urocit-K 10 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
898517Urocit-K 15 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
898517Urocit-K 1620 MG Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
603282Urocit-K 5 MEQ Extended Release Oral TabletSY72cdea1b-2240-41db-987d-86d5c6aaa97828
199381potassium citrate 10 MEQ Extended Release Oral TabletPSNd2c923d5-85c1-4bbb-9f93-556080a5ef871
898490potassium citrate 15 MEQ Extended Release Oral TabletPSNd2c923d5-85c1-4bbb-9f93-556080a5ef871
603281UROCIT-K 10 MEQ Extended Release Oral TabletPSNd2c923d5-85c1-4bbb-9f93-556080a5ef871
898517UROCIT-K 15 MEQ Extended Release Oral TabletPSNd2c923d5-85c1-4bbb-9f93-556080a5ef871
603281potassium citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]SBDd2c923d5-85c1-4bbb-9f93-556080a5ef871
898517potassium citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]SBDd2c923d5-85c1-4bbb-9f93-556080a5ef871
199381potassium citrate 10 MEQ Extended Release Oral TabletSCDd2c923d5-85c1-4bbb-9f93-556080a5ef871
898490potassium citrate 15 MEQ Extended Release Oral TabletSCDd2c923d5-85c1-4bbb-9f93-556080a5ef871
199381K+ citrate 10 MEQ Extended Release Oral TabletSYd2c923d5-85c1-4bbb-9f93-556080a5ef871
603281K+ citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]SYd2c923d5-85c1-4bbb-9f93-556080a5ef871
898490K+ citrate 15 MEQ Extended Release Oral TabletSYd2c923d5-85c1-4bbb-9f93-556080a5ef871
898517K+ citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]SYd2c923d5-85c1-4bbb-9f93-556080a5ef871
199381Pot citrate 10 MEQ Extended Release Oral TabletSYd2c923d5-85c1-4bbb-9f93-556080a5ef871
603281Pot citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]SYd2c923d5-85c1-4bbb-9f93-556080a5ef871
898490Pot citrate 15 MEQ Extended Release Oral TabletSYd2c923d5-85c1-4bbb-9f93-556080a5ef871
898517Pot citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]SYd2c923d5-85c1-4bbb-9f93-556080a5ef871
199381potassium citrate 1080 MG Extended Release Oral TabletSYd2c923d5-85c1-4bbb-9f93-556080a5ef871
898490potassium citrate 1620 MG Extended Release Oral TabletSYd2c923d5-85c1-4bbb-9f93-556080a5ef871
603281Urocit-K 10 MEQ Extended Release Oral TabletSYd2c923d5-85c1-4bbb-9f93-556080a5ef871
898517Urocit-K 15 MEQ Extended Release Oral TabletSYd2c923d5-85c1-4bbb-9f93-556080a5ef871
898517Urocit-K 1620 MG Extended Release Oral TabletSYd2c923d5-85c1-4bbb-9f93-556080a5ef871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0178-0615-0100178061501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0178-0615-01) 2010-01-270000-00-00NoNoCurrent