K-Tab

Product NDC
0074-3058
11-digit product format
000743058
Labeler code
0074
Product ID
0074-3058_2babd1a6-739a-462b-bb4e-bf9fc8b477ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AbbVie Inc.
Application
NDA018279
Marketing category
NDA
Marketing start
1980-06-09
Marketing end
2022-08-01
Substance
POTASSIUM CHLORIDE
Active strength
600 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
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0074-3058DDiscontinued by firm2026-10-15
excluded packagepackage0074-30580074-3058-41DDiscontinued by firm2026-10-15
excluded packagepackage0074-30580074-3058-46DDiscontinued by firm2026-10-15

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 · 36 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 packagepackage0074-3058-41d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0074-3058-46d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0074-3058-41f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0074-3058-46f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0074-3058-412ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0074-3058-462ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0074-3058-41a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0074-3058-46a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0074-3058-41cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0074-3058-46cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0074-3058-41cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0074-3058-46cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0074-3058-41302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0074-3058-46302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0074-3058-41ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0074-3058-46ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0074-3058-410efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0074-3058-460efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0074-3058-41ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0074-3058-46ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0074-3058-41367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0074-3058-46367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0074-3058-41557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0074-3058-46557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018279-001K-TABPOTASSIUM CHLORIDE10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982
N018279-002K-TABPOTASSIUM CHLORIDE8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01
N018279-003K-TABPOTASSIUM CHLORIDE20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982c2088c7a36db…
2026-10-15 13:18:302026-09N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01c2088c7a36db…
2026-10-15 13:18:302026-09N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25c2088c7a36db…
2026-09-14 22:38:342026-08N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-0184e616aacf4f…
2026-09-14 22:38:342026-08N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-2584e616aacf4f…
2026-08-18 06:07:402026-07N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01caaa826d4ba7…
2026-08-18 06:07:402026-07N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018279-002K-TAB8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1988-08-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N018279-003K-TAB20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2013-11-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018279-001K-TAB10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 198279d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 47 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018279-003AB313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018279-001AB31f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N018279-003AB31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018279-001AB31e64feba35796…
2022-09-29 23:25 UTC2022-09N018279-003AB31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018279-001AB31cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018279-003AB31cb3db0bc1861…

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
0074-3058-41EA - Each0074-30582eaa2263-91dd-411e-bb4b-3b9fccf511a512015-07-20
0074-3058-46EA - Each0074-30582d7a0c84-f016-4fe4-b80d-463ec709eac712015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1445
POTASSIUM CATIONACTIVE MOIETY295O53K152K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1445
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1445
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GK-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1445
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GK-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1445
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BK-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1445
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1445
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEK-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1445
POLYVINYL ACETATEINACTIVE INGREDIENT32K497ZK2UK-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1445
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4K-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1445
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPK-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1445
VANILLININACTIVE INGREDIENTCHI530446XK-TAB (POTASSIUM CHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1445

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0074-3058-4100074305841100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3058-41) 1980-06-090000-00-00NoNoCurrent
0074-3058-46000743058461000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3058-46) 1980-06-090000-00-00NoNoCurrent