Potassium Chloride

Product NDC: 71085-083
Requested package NDC: 71085-083-30
11-digit product format: 710850083
Labeler code: 71085
Product ID: 71085-083_0f19da2c-a9ab-44fe-a38b-acb56c1c1883
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Chloride
Dosage form: FOR SOLUTION
Route: ORAL
Labeler: IPG Pharmaceuticals, Inc.
Application: NDA208019
Marketing category: NDA
Marketing start: 2025-12-01
Marketing end: 2028-11-30
Substance: POTASSIUM CHLORIDE
Active strength: 3 g/3.16g
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
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208019-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19
N208019-002	POKONZA	POTASSIUM CHLORIDE	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25
N208019-003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25
N208019-004	POKONZA	POTASSIUM CHLORIDE	15MEQ	FOR SOLUTION / ORAL		RLD	2025-11-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208019-001	AA

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 · 98 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N208019-004	POKONZA	15MEQ	FOR SOLUTION / ORAL		RLD	2025-11-12	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208019-004	POKONZA	15MEQ	FOR SOLUTION / ORAL		RLD	2025-11-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208019-004	POKONZA	15MEQ	FOR SOLUTION / ORAL		RLD	2025-11-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208019-004	POKONZA	15MEQ	FOR SOLUTION / ORAL		RLD	2025-11-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD, RS	2015-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD, RS	2015-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD, RS	2015-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	N208019-001	AA	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N208019-001	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208019-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208019-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208019-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208019-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208019-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208019-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208019-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208019-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208019-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208019-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208019-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208019-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208019-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208019-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208019-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208019-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208019-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208019-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208019-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208019-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208019-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208019-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208019-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208019-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208019-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208019-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208019-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208019-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208019-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208019-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208019-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208019-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208019-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208019-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208019-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208019-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208019-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208019-001	AA	1	`3bdfa0b2c4d7…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Potassium Chloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CHLORIDE	3 g/3.16g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
660YQ98I10	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2728724	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5dad0879-0f97-4c7d-98fa-baaed51cd2d8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
d9771140-739b-484b-ae64-b79528ff1211	Product name	3	20250801
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71085-083-01	Potassium Chloride	3.16 g in 1 POUCH	FOR SOLUTION	3.16		1
71085-083-30	Potassium Chloride	30 in 1 CARTON	FOR SOLUTION	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71085-083-01	EA - Each	71085-083	ef3a2316-8641-4eb4-ac0b-0790fdfba21b	1	2026-01-08
71085-083-30	EA - Each	71085-083	ebe4794c-6d2e-48e0-b499-e432cf738970	1	2026-01-08

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POKONZA	POTASSIUM CHLORIDE	Carwin Pharmaceutical Associates, LLC	0700c19e-abca-4527-8944-e4440a32e3af	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208019 application number: NDA208019
Potassium Chloride	POTASSIUM CHLORIDE	Endo USA, Inc.	a64d7151-09a6-474c-83fc-36c7cf582d32	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208019 application number: NDA208019
POKONZA	POTASSIUM CHLORIDE	Carwin Pharmaceutical Associates, LLC	7c5cc705-e5da-4487-86c9-9d545a95afb4	2024-03-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208019 application number: NDA208019
Potassium Chloride	POTASSIUM CHLORIDE	Genus Lifesciences Inc.	23d818e7-c076-40de-8dc1-0b51ba4be96a	2020-04-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208019 application number: NDA208019

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
660YQ98I10	POTASSIUM CHLORIDE	7447-40-7	POTASSIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2728724	potassium chloride 40 MEQ (3 GM) Powder for Oral Solution	PSN	5dad0879-0f97-4c7d-98fa-baaed51cd2d8	1
2728724	potassium chloride 40 MEQ Powder for Oral Solution	SCD	5dad0879-0f97-4c7d-98fa-baaed51cd2d8	1
2728724	K+ chloride 40 MEQ Powder for Oral Solution	SY	5dad0879-0f97-4c7d-98fa-baaed51cd2d8	1
2728724	Pot chloride 40 MEQ Powder for Oral Solution	SY	5dad0879-0f97-4c7d-98fa-baaed51cd2d8	1
2728724	potassium chloride 3 GM Powder for Oral Solution	SY	5dad0879-0f97-4c7d-98fa-baaed51cd2d8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71085-083-30	71085008330	30 POUCH in 1 CARTON (71085-083-30) / 3.16 g in 1 POUCH (71085-083-01)	30 pouch	2025-12-01	2028-11-30	No	No	Historical