Potassium chloride extended release

Product NDC
63629-8700
11-digit product format
636298700
Labeler code
63629
Product ID
63629-8700_e5479e84-3fba-4994-9bff-62492dc06969
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205993
Marketing category
ANDA
Marketing start
2015-12-11
Marketing end
0000-00-00
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
2023-12-31
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 productproduct63629-8700DDiscontinued by firm2026-10-20
excluded packagepackage63629-870063629-8700-1DDiscontinued by firm2026-10-20

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 packagepackage63629-8700-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-8700-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-8700-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-8700-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-8700-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-8700-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-8700-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-8700-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-8700-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-8700-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-8700-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-8700-1557ba5c1ecfa…9c80585c8c6e…

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

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
A205993-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05
A205993-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205993-001AB2
A205993-002AB2

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.

Product history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05c2088c7a36db…
2026-10-15 13:18:302026-09A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05c2088c7a36db…
2026-09-14 22:38:342026-08A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0584e616aacf4f…
2026-09-14 22:38:342026-08A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0584e616aacf4f…
2026-08-18 06:07:402026-07A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205993-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205993-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22015-11-054b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A205993-001AB2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205993-002AB2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205993-001AB21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205993-002AB21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205993-001AB21782e0a99824c…
2021-12-28 21:50 UTC2021-12A205993-002AB21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205993-001AB2187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205993-002AB2187673890dc5c…
2021-03-12 10:30 UTC2021-03A205993-001AB215aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A205993-002AB215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205993-001AB218869cabd3fbd…
2020-12-22 03:56 UTC2020-12A205993-002AB218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205993-001AB21c0c555d07b60…
2020-11-12 02:37 UTC2020-11A205993-002AB21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205993-001AB213f01610625f2…
2019-12-14 00:12 UTC2019-12A205993-002AB213f01610625f2…
2019-09-15 20:21 UTC2019-09A205993-001AB21b00525d2431f…
2019-09-15 20:21 UTC2019-09A205993-002AB21b00525d2431f…
2019-07-19 19:46 UTC2019-07A205993-001AB21ea99ee380514…
2019-07-19 19:46 UTC2019-07A205993-002AB21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205993-001AB216a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205993-002AB216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205993-001AB211c564ffb4f44…
2024-02-18 07:12 UTC2024-02A205993-002AB211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205993-001AB21ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A205993-002AB21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205993-001AB21a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205993-002AB21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205993-001AB219b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205993-002AB219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205993-001AB21a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205993-002AB21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205993-001AB213f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205993-002AB213f0d92c62455…
2023-05-13 08:27 UTC2023-05A205993-001AB21053a50430f4f…
2023-05-13 08:27 UTC2023-05A205993-002AB21053a50430f4f…
2023-01-26 05:58 UTC2023-01A205993-001AB213bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A205993-002AB213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205993-001AB213a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205993-002AB213a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8700-163629870001500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8700-1) 2016-01-120000-00-00NoNoCurrent