FDA.reportPublic FDA data

Potassium Chloride

Product NDC
68382-600
11-digit product format
683820600
Labeler code
68382
Product ID
68382-600_c3887ec5-c66d-4d1b-bab1-07bf0e8b3d47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc
Application
NDA018279
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-02-22
Marketing end
0000-00-00
Substance
POTASSIUM CHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
68382-600-012020-02-25C16284748780-19d75b9d0-d411-f424-e053-dadaa90a57ce8d140d5e-a5d7-5302-3572-e606dd247410
68382-600-102020-02-25C16284748780-19d75b9d0-d411-f424-e053-dadaa90a57ce8d140d5e-a5d7-5302-3572-e606dd247410
68382-600-012020-01-31C16284748780-19d75b9d0-d411-f424-e053-dadaa90a57ce8d140d5e-a5d7-5302-3572-e606dd247410
68382-600-102020-01-31C16284748780-19d75b9d0-d411-f424-e053-dadaa90a57ce8d140d5e-a5d7-5302-3572-e606dd247410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-600-01EA - Each68382-6002a030905-ff71-4442-9991-bbddd650ec9112012-07-24
68382-600-10EA - Each68382-600574b8ab1-0d70-41de-a0a0-aa8b6007ecfd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
POTASSIUM CATIONACTIVE MOIETY295O53K152POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
POLYVINYL ACETATEINACTIVE INGREDIENT32K497ZK2UPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
VANILLININACTIVE INGREDIENTCHI530446XPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
POTASSIUM CATIONACTIVE MOIETY295O53K152POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
POTASSIUM CATIONACTIVE MOIETY295O53K152POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
POLYVINYL ACETATEINACTIVE INGREDIENT32K497ZK2UPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
VANILLININACTIVE INGREDIENTCHI530446XPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
VANILLININACTIVE INGREDIENTCHI530446XPOTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN40ba25e2-981d-3454-e054-00144ff8d46c4
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN418fa94a-9e92-4f06-b8c2-020c885e34124
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD40ba25e2-981d-3454-e054-00144ff8d46c4
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD418fa94a-9e92-4f06-b8c2-020c885e34124
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY40ba25e2-981d-3454-e054-00144ff8d46c4
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY418fa94a-9e92-4f06-b8c2-020c885e34124
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY40ba25e2-981d-3454-e054-00144ff8d46c4
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY418fa94a-9e92-4f06-b8c2-020c885e34124
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY40ba25e2-981d-3454-e054-00144ff8d46c4
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY418fa94a-9e92-4f06-b8c2-020c885e34124
628953potassium chloride 750 MG Extended Release Oral TabletSY418fa94a-9e92-4f06-b8c2-020c885e34124
628953potassium chloride 750 MG Extended Release Oral TabletSY40ba25e2-981d-3454-e054-00144ff8d46c4
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSNf5adfe63-62a8-4453-a0f0-db3076e01d783
628953potassium chloride 10 MEQ Extended Release Oral TabletSCDf5adfe63-62a8-4453-a0f0-db3076e01d783
628953K+ Chloride 10 MEQ Extended Release Oral TabletSYf5adfe63-62a8-4453-a0f0-db3076e01d783
628953Pot Chloride 10 MEQ Extended Release Oral TabletSYf5adfe63-62a8-4453-a0f0-db3076e01d783
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSYf5adfe63-62a8-4453-a0f0-db3076e01d783
628953potassium chloride 750 MG Extended Release Oral TabletSYf5adfe63-62a8-4453-a0f0-db3076e01d783
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSNeb4939b8-1d90-4e56-8e59-40733d7007442
628953potassium chloride 10 MEQ Extended Release Oral TabletSCDeb4939b8-1d90-4e56-8e59-40733d7007442
628953K+ Chloride 10 MEQ Extended Release Oral TabletSYeb4939b8-1d90-4e56-8e59-40733d7007442
628953Pot Chloride 10 MEQ Extended Release Oral TabletSYeb4939b8-1d90-4e56-8e59-40733d7007442
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSYeb4939b8-1d90-4e56-8e59-40733d7007442
628953potassium chloride 750 MG Extended Release Oral TabletSYeb4939b8-1d90-4e56-8e59-40733d7007442
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSNc4c5fe65-b476-482a-8e53-36f7be4748dc1
628953potassium chloride 10 MEQ Extended Release Oral TabletSCDc4c5fe65-b476-482a-8e53-36f7be4748dc1
628953K+ Chloride 10 MEQ Extended Release Oral TabletSYc4c5fe65-b476-482a-8e53-36f7be4748dc1
628953Pot Chloride 10 MEQ Extended Release Oral TabletSYc4c5fe65-b476-482a-8e53-36f7be4748dc1
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSYc4c5fe65-b476-482a-8e53-36f7be4748dc1
628953potassium chloride 750 MG Extended Release Oral TabletSYc4c5fe65-b476-482a-8e53-36f7be4748dc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-600-0168382060001100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-600-01) 2011-02-220000-00-00NoNoCurrent
68382-600-10683820600101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-600-10) 2011-02-220000-00-00NoNoCurrent