Home NDC 0603-3508-16 Effervescent Potassium Chloride
Product NDC 0603-3508
Requested package NDC 0603-3508-16
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
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LYSINE HYDROCHLORIDE ACTIVE INGREDIENT JNJ23Q2COM EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS] 3 POTASSIUM BICARBONATE ACTIVE INGREDIENT HM5Z15LEBN EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS] 3 POTASSIUM CHLORIDE ACTIVE INGREDIENT 660YQ98I10 EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS] 3 BICARBONATE ION ACTIVE MOIETY HN1ZRA3Q20 EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS] 3 CHLORIDE ION ACTIVE MOIETY Q32ZN48698 EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS] 3 LYSINE ACTIVE MOIETY K3Z4F929H6 EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS] 3 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS] 3 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS] 3 SACCHARIN SODIUM ANHYDROUS INACTIVE INGREDIENT I4807BK602 EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU EFFERVESCENT POTASSIUM CHLORIDE (POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION) TABLET, EFFERVESCENT [QUALITEST PHARMACEUTICALS] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R EFFERVESCENT 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 NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0603-3508-16 00603350816 30 TABLET, EFFERVESCENT in 1 BOX (0603-3508-16) 2006-01-06 2021-07-31 No No Current