POTASSIUM CHLORIDE

Product NDC: 59917-102
Requested package NDC: 59917-102-00
11-digit product format: 599170102
Labeler code: 59917
Product ID: 59917-102_0cf861f5-7a8c-9ba4-e063-6294a90a601f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: POTASSIUM CHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: Adare Pharmaceuticals Inc
Application: ANDA208864
Marketing category: ANDA
Marketing start: 2018-04-01
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: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	59917-102	59917-102-00	UNFINISHED	Active or certified unfinished drug listing		2026-08-10

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 · 10 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208864-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-03-17
A208864-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208864-001	AB
A208864-002	AB

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208864-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208864-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-03-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208864-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208864-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208864-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208864-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208864-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208864-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208864-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208864-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208864-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208864-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208864-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208864-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208864-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208864-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208864-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208864-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208864-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208864-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208864-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208864-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208864-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208864-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208864-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208864-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208864-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208864-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208864-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208864-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208864-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208864-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208864-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208864-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208864-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208864-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208864-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208864-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208864-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208864-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208864-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208864-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: POTASSIUM CHLORIDE
Brand name suffix: EXTENDED RELEASE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CHLORIDE	600 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312504	Internal RxNorm lookup
315183	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
22edb0e6-4e45-4e91-aead-3581cca293a0	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	SPL version
59917-102-01	POTASSIUM CHLORIDEEXTENDED RELEASE	1 in 1 CAPSULE	CAPSULE	1	9
59917-102-01	POTASSIUM CHLORIDEEXTENDED RELEASE	100 in 1 BOTTLE, PLASTIC	CAPSULE	100	9
59917-102-05	POTASSIUM CHLORIDEEXTENDED RELEASE	500 in 1 BOTTLE, PLASTIC	CAPSULE	500	9
59917-102-05	POTASSIUM CHLORIDEEXTENDED RELEASE	1 in 1 CAPSULE	CAPSULE	1	9
59917-102-10	POTASSIUM CHLORIDEEXTENDED RELEASE	1000 in 1 BOTTLE, PLASTIC	CAPSULE	1000	9
59917-102-10	POTASSIUM CHLORIDEEXTENDED RELEASE	1 in 1 CAPSULE	CAPSULE	1	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59917-102-01	EA - Each	59917-102	d96d0973-5333-4172-ab8a-1afa40edc4a5	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59917-102	POTASSIUM CHLORIDE EXTENDED RELEASE (POTASSIUM CHLORIDE) CAPSULE [ADARE PHARMACEUTICALS INC]	9	Current NDC, Legacy NDC, 6 package rows	20231221_22edb0e6-4e45-4e91-aead-3581cca293a0.zip

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	018fc687-1fba-202e-e063-6294a90a5c9a	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208864 application number: ANDA208864
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	cc15ef60-6956-4d34-b86d-72cdd0c0c0bb	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208864 application number: ANDA208864
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	ccaaa3a2-a273-41c7-9e54-429539ea0140	2024-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208864 application number: ANDA208864
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	American Health Packaging	96ea00f5-b922-4d57-b2ac-34523ea56d5f	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208864 application number: ANDA208864
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Bryant Ranch Prepack	65e30d1a-50e9-4b84-ad4d-daaea91eab4b	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208864 application number: ANDA208864
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Sun Pharmaceutical Industries, Inc.	4d90d03d-7f0e-4d49-9e80-628dbc7165c0	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208864 application number: ANDA208864
POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Adare Pharmaceuticals Inc	22edb0e6-4e45-4e91-aead-3581cca293a0	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208864 application number: ANDA208864 ndc (product): 59917-102

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
312504	potassium chloride 10 MEQ Extended Release Oral Capsule	PSN	22edb0e6-4e45-4e91-aead-3581cca293a0	9
315183	potassium chloride 8 MEQ (600 MG) Extended Release Oral Capsule	PSN	22edb0e6-4e45-4e91-aead-3581cca293a0	9
312504	potassium chloride 10 MEQ Extended Release Oral Capsule	SCD	22edb0e6-4e45-4e91-aead-3581cca293a0	9
315183	potassium chloride 8 MEQ Extended Release Oral Capsule	SCD	22edb0e6-4e45-4e91-aead-3581cca293a0	9
312504	K+ Chloride 10 MEQ Extended Release Oral Capsule	SY	22edb0e6-4e45-4e91-aead-3581cca293a0	9
315183	K+ Chloride 8 MEQ Extended Release Oral Capsule	SY	22edb0e6-4e45-4e91-aead-3581cca293a0	9
312504	Pot Chloride 10 MEQ Extended Release Oral Capsule	SY	22edb0e6-4e45-4e91-aead-3581cca293a0	9
315183	Pot Chloride 8 MEQ Extended Release Oral Capsule	SY	22edb0e6-4e45-4e91-aead-3581cca293a0	9
315183	potassium chloride 600 MG Extended Release Oral Capsule	SY	22edb0e6-4e45-4e91-aead-3581cca293a0	9
312504	potassium chloride 750 MG Extended Release Oral Capsule	SY	22edb0e6-4e45-4e91-aead-3581cca293a0	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
59917-102-00	59917010200	1 BAG in 1 DRUM (59917-102-00) / 54035 CAPSULE in 1 BAG	1 bag	01-APR-18	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Potassium Chloride Extended-release Capsules, USP, 8 mEq and 10 mEq	Adare Pharmaceuticals Inc	2023-12-20	HUMAN PRESCRIPTION DRUG LABEL	9
Potassium Chloride Extended-release Capsules, USP, 8 mEq	PD-Rx Pharmaceuticals, Inc.	2021-12-10	HUMAN PRESCRIPTION DRUG LABEL	10