FDA.reportPublic FDA data

Potassium Chloride

Product NDC
63304-987
11-digit product format
633040987
Labeler code
63304
Product ID
63304-987_0a1f3d5d-13ce-97b3-e063-6394a90aa250
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076368
Marketing category
ANDA
Marketing start
2023-11-14
Substance
POTASSIUM CHLORIDE
Active strength
20 meq/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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE20 meq/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii660YQ98I10
Rxcui1801294

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-987-01Potassium Chloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
63304-987-05Potassium Chloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5001
63304-987-10Potassium Chloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-987-01EA - Each63304-9877ef1c3e0-d5e0-4d7c-941c-dc75ed1df6f912023-12-05
63304-987-05EA - Each63304-987e5e11590-c6d1-4983-a327-8fa33300521a12023-12-05
63304-987-10EA - Each63304-987f772749c-80ac-440a-9783-f05d7c499c1d12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-987POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]1Current NDC, 3 package rows20231115_0a1f2f64-3b0b-5e5c-e063-6294a90a7185.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSN47a87fb6-5e61-41c9-b759-10f7c74a67ce9
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCD47a87fb6-5e61-41c9-b759-10f7c74a67ce9
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSY47a87fb6-5e61-41c9-b759-10f7c74a67ce9
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSY47a87fb6-5e61-41c9-b759-10f7c74a67ce9
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSY47a87fb6-5e61-41c9-b759-10f7c74a67ce9
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSY47a87fb6-5e61-41c9-b759-10f7c74a67ce9
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSN0a1f2f64-3b0b-5e5c-e063-6294a90a71851
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSN5c2e888c-2f1e-4d5a-a456-20774ca833021
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCD0a1f2f64-3b0b-5e5c-e063-6294a90a71851
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCD5c2e888c-2f1e-4d5a-a456-20774ca833021
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSY0a1f2f64-3b0b-5e5c-e063-6294a90a71851
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSY5c2e888c-2f1e-4d5a-a456-20774ca833021
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSY5c2e888c-2f1e-4d5a-a456-20774ca833021
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSY0a1f2f64-3b0b-5e5c-e063-6294a90a71851
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSY5c2e888c-2f1e-4d5a-a456-20774ca833021
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSY0a1f2f64-3b0b-5e5c-e063-6294a90a71851
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSY5c2e888c-2f1e-4d5a-a456-20774ca833021
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSY0a1f2f64-3b0b-5e5c-e063-6294a90a71851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63304-987-0163304098701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-987-01) 2023-11-14NoNoCurrent
63304-987-0563304098705500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-987-05) 2023-11-14NoNoCurrent
63304-987-10633040987101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-987-10) 2023-11-14NoNoCurrent