Effervescent Potassium Chloride

Product NDC
0603-3508
11-digit product format
006033508
Labeler code
0603
Product ID
0603-3508_71ebe1c1-4b74-9cab-e053-2a95a90a90ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Bicarbonate and Potassium Chloride Effervescent Tablets for Oral Solution
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Qualitest Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2006-01-06
Marketing end
2021-07-31
Substance
POTASSIUM CHLORIDE; POTASSIUM BICARBONATE; LYSINE HYDROCHLORIDE
Active strength
1 g/1; g/1; g/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],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
0000-00-00
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 productproduct0603-3508DDiscontinued by firm2026-10-05
excluded packagepackage0603-35080603-3508-16DDiscontinued by firm2026-10-05

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-3508-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-3508-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-3508-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-3508-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-3508-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-3508-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-3508-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-3508-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-3508-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-3508-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-3508-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-3508-16557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-3508-16EA - Each0603-350864e16d23-d6c1-4fb5-a767-5dff79ed1a7e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LYSINE HYDROCHLORIDEACTIVE INGREDIENTJNJ23Q2COMEFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS]3
POTASSIUM BICARBONATEACTIVE INGREDIENTHM5Z15LEBNEFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS]3
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS]3
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q20EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS]3
CHLORIDE IONACTIVE MOIETYQ32ZN48698EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS]3
LYSINEACTIVE MOIETYK3Z4F929H6EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPEFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BEFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS]3
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS]3
SORBITOLINACTIVE INGREDIENT506T60A25REFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0603-3508-160060335081630 TABLET, EFFERVESCENT in 1 BOX (0603-3508-16) 2006-01-062021-07-31NoNoCurrent