FDA.reportPublic FDA data

Potassium Chloride Extended-release

Product NDC
17856-1135
11-digit product format
178561135
Labeler code
17856
Product ID
17856-1135_4e41df31-dd11-84fa-e063-6394a90a8468
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride Extended-release
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Atlantic Biologicals Corp.
Application
ANDA214452
Marketing category
ANDA
Marketing start
2021-01-30
Substance
POTASSIUM CHLORIDE
Active strength
1500 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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214452-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21
A214452-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A214452-001AB1
A214452-002AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A214452-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21a50c72e98297…
2026-08-01 22:54:322026-06A214452-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12020-10-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214452-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A214452-002AB11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEREMEDYREPACK INC.2c407aaf-5d95-49ff-a5db-f1d7b51903342026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASERedpharm Drug37455920-e408-5906-e063-6294a90a57ae2026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEAtlantic Biologicals Corp.4d7ad5c6-2c18-dc29-e063-6394a90a621e2026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
ndc (product): 17856-1135
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEREMEDYREPACK INC.ace1eb11-b925-405a-b772-58c60b3ca7d42025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEGranules India Ltd60285a8d-bcb0-40ba-b359-df5c89480cd62025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride ERPOTASSIUM CHLORIDE ERDirect_Rx42c92fcc-21d2-d32a-e063-6294a90a83122025-11-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEBluepoint Laboratoriesd605ca36-2bfa-42cb-a46c-8ecb3162994e2025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEA-S Medication Solutionsde335131-bb8a-44e5-89fa-1478edbcdc0e2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEA-S Medication Solutionsedb6c987-e2c3-421f-8a8d-849c9e17ace82025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEGranules Pharmaceuticals Inc.b3d4d5b5-2898-ae3d-e053-2a95a90a6d042025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEPreferred Pharmaceuticals Inc.87f369cf-40e5-4f91-aa42-ae986fce65442025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride ERPOTASSIUM CHLORIDE ERDirect_Rx377854ff-8034-c7ac-e063-6294a90a08172025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDE EXTENDED-RELEASENCS HealthCare of KY, LLC dba Vangard Labsc684758c-16f0-4bd9-b719-1aae64b7907f2025-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEProficient Rx LPf191b15c-7959-4aa6-a2ef-617cde77c9182024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEBryant Ranch Prepackb5505a39-57f1-4ed5-b845-4f1d8aa109502024-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEBryant Ranch Prepack7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb2024-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEProficient Rx LPc53d1db5-1c9e-4289-a2a2-961e0dd56f322024-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214452
application number: ANDA214452

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Chloride Extended-release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE1500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
660YQ98I10Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1801294Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d7ad5c6-2c18-dc29-e063-6394a90a621eAvailable on FDA.report

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
17856-1135-1Potassium Chloride Extended-release1 in 1 POUCHTABLET, EXTENDED RELEASE12
17856-1135-1Potassium Chloride Extended-release100 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE1002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletPSN4d7ad5c6-2c18-dc29-e063-6394a90a621e2
1801294Microencapsulated potassium chloride 20 MEQ Extended Release Oral TabletSCD4d7ad5c6-2c18-dc29-e063-6394a90a621e2
1801294Microencapsulated K+ Chloride 20 MEQ Extended Release Oral TabletSY4d7ad5c6-2c18-dc29-e063-6394a90a621e2
1801294Microencapsulated Pot Chloride 20 MEQ Extended Release Oral TabletSY4d7ad5c6-2c18-dc29-e063-6394a90a621e2
1801294potassium chloride 1500 MG Microencapsulated Extended Release Oral TabletSY4d7ad5c6-2c18-dc29-e063-6394a90a621e2
1801294potassium chloride 20 MEQ Microencapsulated Extended Release Oral TabletSY4d7ad5c6-2c18-dc29-e063-6394a90a621e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-1135-117856113501100 POUCH in 1 BOX, UNIT-DOSE (17856-1135-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH100 pouch2021-01-30NoNoCurrent