FDA.reportPublic FDA data

K-Tab

Product NDC
43353-790
11-digit product format
433530790
Labeler code
43353
Product ID
43353-790_7c37fbd5-1883-41e4-ac9b-cc4b5ca3efd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA018279
Marketing category
NDA
Marketing start
1980-06-09
Marketing end
0000-00-00
Substance
POTASSIUM CHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-790-302020-01-31C16284748780-19d75b9d0-7bc7-f424-e053-dadaa90a57ceK-TAB® (potassium chloride extended-release tablets, USP)
43353-790-532020-01-31C16284748780-19d75b9d0-7bc7-f424-e053-dadaa90a57ceK-TAB® (potassium chloride extended-release tablets, USP)
43353-790-602020-01-31C16284748780-19d75b9d0-7bc7-f424-e053-dadaa90a57ceK-TAB® (potassium chloride extended-release tablets, USP)
43353-790-702020-01-31C16284748780-19d75b9d0-7bc7-f424-e053-dadaa90a57ceK-TAB® (potassium chloride extended-release tablets, USP)
43353-790-802020-01-31C16284748780-19d75b9d0-7bc7-f424-e053-dadaa90a57ceK-TAB® (potassium chloride extended-release tablets, USP)
43353-790-852020-01-31C16284748780-19d75b9d0-7bc7-f424-e053-dadaa90a57ceK-TAB® (potassium chloride extended-release tablets, USP)
43353-790-922020-01-31C16284748780-19d75b9d0-7bc7-f424-e053-dadaa90a57ceK-TAB® (potassium chloride extended-release tablets, USP)
43353-790-942020-01-31C16284748780-19d75b9d0-7bc7-f424-e053-dadaa90a57ceK-TAB® (potassium chloride extended-release tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-790-30K-Tab30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE302
43353-790-53K-Tab60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE602
43353-790-60K-Tab90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE902
43353-790-70K-Tab120 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1202
43353-790-80K-Tab180 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1802
43353-790-85K-Tab200 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE2002
43353-790-92K-Tab270 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE2702
43353-790-94K-Tab360 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE3602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-790-30EA - Each43353-790701b79e2-bc27-438a-9a7d-24a22d79f23912014-06-03
43353-790-53EA - Each43353-790fe474b8d-cbe8-40b6-a11b-baa406fa2b7212013-04-01
43353-790-60EA - Each43353-7903f61f346-3b13-4d39-bc36-34cc31e9c6f812013-04-01
43353-790-70EA - Each43353-79056e19e03-98dc-4092-b0cc-12ba559cc9ef12014-06-03
43353-790-80EA - Each43353-7906141dba5-beb2-41ee-bb18-dbf6baff2fd012013-04-01
43353-790-92EA - Each43353-790bb868a0d-3a12-42e9-85cc-12807870a38d12013-04-01
43353-790-94EA - Each43353-790f2463cac-72cc-445c-ba5f-d69b84440e7d12013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POTASSIUM CATIONACTIVE MOIETY295O53K152K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GK-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GK-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BK-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEK-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPK-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
VANILLININACTIVE INGREDIENTCHI530446XK-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-790K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 8 package rows20140416_d87dff5c-4e55-480d-b8ee-ab19d2280f92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
670031K-Tab 10 MEQ (750 MG) Extended Release Oral TabletPSNd87dff5c-4e55-480d-b8ee-ab19d2280f922
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSNd87dff5c-4e55-480d-b8ee-ab19d2280f922
670031potassium chloride 10 MEQ Extended Release Oral Tablet [K-Tab]SBDd87dff5c-4e55-480d-b8ee-ab19d2280f922
628953potassium chloride 10 MEQ Extended Release Oral TabletSCDd87dff5c-4e55-480d-b8ee-ab19d2280f922
670031K-Tab 10 MEQ Extended Release Oral TabletSYd87dff5c-4e55-480d-b8ee-ab19d2280f922
628953K+ Chloride 10 MEQ Extended Release Oral TabletSYd87dff5c-4e55-480d-b8ee-ab19d2280f922
670031K+ Chloride 10 MEQ Extended Release Oral Tablet [K-Tab]SYd87dff5c-4e55-480d-b8ee-ab19d2280f922
628953Pot Chloride 10 MEQ Extended Release Oral TabletSYd87dff5c-4e55-480d-b8ee-ab19d2280f922
670031Pot Chloride 10 MEQ Extended Release Oral Tablet [K-Tab]SYd87dff5c-4e55-480d-b8ee-ab19d2280f922
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSYd87dff5c-4e55-480d-b8ee-ab19d2280f922
628953potassium chloride 750 MG Extended Release Oral TabletSYd87dff5c-4e55-480d-b8ee-ab19d2280f922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-790-304335307903030 in 1 BOTTLE, PLASTICHistorical
43353-790-534335307905360 in 1 BOTTLE, PLASTICHistorical
43353-790-604335307906090 in 1 BOTTLE, PLASTICHistorical
43353-790-7043353079070120 in 1 BOTTLE, PLASTICHistorical
43353-790-8043353079080180 in 1 BOTTLE, PLASTICHistorical
43353-790-8543353079085200 in 1 BOTTLE, PLASTICHistorical
43353-790-9243353079092270 in 1 BOTTLE, PLASTICHistorical
43353-790-9443353079094360 in 1 BOTTLE, PLASTICHistorical