FDA.reportPublic FDA data

POTASSIUM CHLORIDE EXTENDED RELEASE

Product NDC
16571-843
Requested package NDC
16571-843-01
11-digit product format
165710843
Labeler code
16571
Product ID
16571-843_1e184d68-6ad3-484c-9b26-dc835ed91cbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA217412
Marketing category
ANDA
Marketing start
2025-02-13
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16571-84316571-843-01DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16571-84316571-843-01DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16571-84316571-843-01DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A217412-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19
A217412-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217412-001AB2
A217412-002AB2

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
2026-08-18 06:07:402026-07A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-198072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-196a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-191c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-191c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217412-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217412-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22023-12-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217412-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A217412-002AB21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217412-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217412-002AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217412-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217412-002AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217412-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217412-002AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217412-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217412-002AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217412-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217412-002AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217412-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217412-002AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217412-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217412-002AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217412-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217412-002AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217412-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217412-002AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217412-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A217412-002AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217412-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217412-002AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217412-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217412-002AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217412-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217412-002AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217412-001AB218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217412-002AB218072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217412-001AB216a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217412-002AB216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217412-001AB211c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217412-002AB211c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217412-001AB21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217412-002AB21a50c72e98297…

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312529Internal RxNorm lookup
628953Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
947c11ca-ca0c-42df-8cc5-3db06458ca5bAvailable 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
16571-843-01POTASSIUM CHLORIDE EXTENDED RELEASE100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
16571-843-10POTASSIUM CHLORIDE EXTENDED RELEASE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10007
16571-843-50POTASSIUM CHLORIDE EXTENDED RELEASE500 in 1 BOTTLETABLET, EXTENDED RELEASE5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-843-01EA - Each16571-8439fab9f26-675d-486c-ae7b-2f74a7dd60d212025-05-14
16571-843-50EA - Each16571-84350588f01-76cf-4c62-a093-aa86b256143412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-843POTASSIUM CHLORIDE EXTENDED RELEASE (POTASSIUM CHLORIDE) TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]6Current NDC, 3 package rows20250221_947c11ca-ca0c-42df-8cc5-3db06458ca5b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDERising Pharma Holdings, Inc.947c11ca-ca0c-42df-8cc5-3db06458ca5b2026-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217412
application number: ANDA217412
ndc (package): 16571-843-01
ndc (product): 16571-843
ndc11 (package): 16571084301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN947c11ca-ca0c-42df-8cc5-3db06458ca5b7
312529potassium chloride 8 MEQ (600 MG) Extended Release Oral TabletPSN947c11ca-ca0c-42df-8cc5-3db06458ca5b7
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD947c11ca-ca0c-42df-8cc5-3db06458ca5b7
312529potassium chloride 8 MEQ Extended Release Oral TabletSCD947c11ca-ca0c-42df-8cc5-3db06458ca5b7
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY947c11ca-ca0c-42df-8cc5-3db06458ca5b7
312529K+ Chloride 8 MEQ Extended Release Oral TabletSY947c11ca-ca0c-42df-8cc5-3db06458ca5b7
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY947c11ca-ca0c-42df-8cc5-3db06458ca5b7
312529Pot Chloride 8 MEQ Extended Release Oral TabletSY947c11ca-ca0c-42df-8cc5-3db06458ca5b7
312529potassium chloride 600 MG Extended Release Oral TabletSY947c11ca-ca0c-42df-8cc5-3db06458ca5b7
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY947c11ca-ca0c-42df-8cc5-3db06458ca5b7
628953potassium chloride 750 MG Extended Release Oral TabletSY947c11ca-ca0c-42df-8cc5-3db06458ca5b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
16571-843-0116571084301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-843-01) 2025-02-13NoNoCurrent