FDA.reportPublic FDA data

Potassium Chloride Extended-Release

Product NDC
0904-7547
11-digit product format
009047547
Labeler code
0904
Product ID
0904-7547_7d74652b-3513-4ebb-8b47-10b3603d04a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA076368
Marketing category
ANDA
Marketing start
2026-02-04
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
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
A076368-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12004-08-18
A076368-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12019-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076368-001AB1
A076368-002AB1

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 22:54:322026-06A076368-001POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12004-08-18a50c72e98297…
2026-08-01 22:54:322026-06A076368-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12019-06-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076368-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A076368-002AB11a50c72e98297…

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 CHLORIDEBryant Ranch Prepackff44dcd5-b255-4d80-83ee-3c8f922c99eb2026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEREMEDYREPACK INC.7ec22e8e-6643-44fe-804d-ca0b0b2666632026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium ChloridePOTASSIUM CHLORIDEMajor Pharmaceuticals5c2e888c-2f1e-4d5a-a456-20774ca833022026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEMajor Pharmaceuticals7d74652b-3513-4ebb-8b47-10b3603d04a72026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
ndc (product): 0904-7547
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack2feda15e-f325-41fe-a442-41a8cc62b8552025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack6fc9eef0-3dfc-4344-85c7-9f11d9b99b652025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack1b64b0c9-31a2-4ee7-8818-66de906ebeda2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium ChloridePOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.47a87fb6-5e61-41c9-b759-10f7c74a67ce2025-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack55747ef3-9437-4bdc-9ebd-a74d8e2de1cf2024-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack473369cb-3a9b-437c-b08e-8fb38034c5072024-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack863e6980-4a66-48a5-a14f-828a00480c932024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEAmerican Health Packaging8c12c5f8-5950-44e3-9473-a0b95187b43c2024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack7427c29e-55c1-4c30-b091-058c8bec592f2024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack80dd5de2-5066-472b-b1f8-88070a5c73882024-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepackb5a6b6f2-d073-4bd3-a66c-bf34ccabfe512024-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.8ed8ea55-8b15-f718-e053-2a95a90a587a2024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368
Potassium ChloridePOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.0a1f2f64-3b0b-5e5c-e063-6294a90a71852023-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076368
application number: ANDA076368

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 CHLORIDE750 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
1801298Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d74652b-3513-4ebb-8b47-10b3603d04a7Available 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
0904-7547-61Potassium Chloride Extended-Release1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE11
0904-7547-61Potassium Chloride Extended-Release100 in 1 CARTONTABLET, EXTENDED RELEASE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7547-61EA - Each0904-754730166449-faec-4eed-a60d-096d89bd337912026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletPSN7d74652b-3513-4ebb-8b47-10b3603d04a71
1801298Microencapsulated potassium chloride 10 MEQ Extended Release Oral TabletSCD7d74652b-3513-4ebb-8b47-10b3603d04a71
1801298Microencapsulated K+ Chloride 10 MEQ Extended Release Oral TabletSY7d74652b-3513-4ebb-8b47-10b3603d04a71
1801298Microencapsulated Pot Chloride 10 MEQ Extended Release Oral TabletSY7d74652b-3513-4ebb-8b47-10b3603d04a71
1801298potassium chloride 10 MEQ Microencapsulated Extended Release Oral TabletSY7d74652b-3513-4ebb-8b47-10b3603d04a71
1801298potassium chloride 750 MG Microencapsulated Extended Release OralSY7d74652b-3513-4ebb-8b47-10b3603d04a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7547-6100904754761100 BLISTER PACK in 1 CARTON (0904-7547-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2026-02-04NoNoCurrent