potassium chloride

Product NDC
55700-880
11-digit product format
557000880
Labeler code
55700
Product ID
55700-880_64fec7a2-ad5c-40d4-b4df-776b6100f8e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA203562
Marketing category
ANDA
Marketing start
2020-09-03
Marketing end
0000-00-00
Substance
POTASSIUM CHLORIDE
Active strength
1500 mg/1
Pharmacologic classes
Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-880DDiscontinued by firm2026-08-03
excluded packagepackage55700-88055700-880-30DDiscontinued by firm2026-08-03

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-880-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-880-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-880-30DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-880-30DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-880-30DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-880-30DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-880-30DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-880-30DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-880-30IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-880-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-880-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-880-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55700-880-30IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55700-880-30IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55700-880-30IInactivated by FDA1332a3947898…d4bfe170f9cd…

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
A203562-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26
A203562-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203562-001AB1
A203562-002AB1

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203562-001POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A203562-002POTASSIUM CHLORIDE20MEQTABLET, EXTENDED RELEASE / ORALAB12016-07-26782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203562-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203562-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203562-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203562-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203562-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203562-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203562-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203562-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203562-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203562-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203562-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203562-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203562-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203562-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203562-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203562-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203562-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203562-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203562-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A203562-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203562-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203562-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203562-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203562-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203562-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203562-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203562-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203562-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203562-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203562-002AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203562-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203562-002AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203562-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203562-002AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203562-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203562-002AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203562-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203562-002AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203562-001AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A203562-002AB11782e0a99824c…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-880-30EA - Each55700-880c1688e4c-be98-4052-ac05-774e52a87a5712021-03-02

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
potassium chloridePOTASSIUM CHLORIDEGlenmark Pharmaceuticals Inc., USA63bedd99-0596-49d2-ad04-d1d8ac15cc422026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDERedpharm Drug3735d41a-7787-6b92-e063-6294a90add452025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
Potassium Chloride ERPOTASSIUM CHLORIDE ERDirect_Rxf988aa11-60ef-411e-e053-6294a90a522a2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutions3a720078-f455-44ab-a883-e3c13d83a74c2024-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutionscf014023-5300-455f-9f7f-fefb2e3639862024-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDEBryant Ranch Prepackf22606a5-ac9f-44fc-bb7b-08f3cf56c9992024-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562
potassium chloridePOTASSIUM CHLORIDEBryant Ranch Prepackbc42a691-a486-4ece-b9f7-faf6cc5df6b52024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203562
application number: ANDA203562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-880-305570008803030 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-880-30) 2020-09-030000-00-00NoNoCurrent