POTASSIUM CHLORIDE

Product NDC: 70518-3384
Requested package NDC: 70518-3384-0
11-digit product format: 705183384
Labeler code: 70518
Product ID: 70518-3384_d9f1db05-4113-2a8f-e053-2a95a90ae0b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: POTASSIUM CHLORIDE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA208864
Marketing category: ANDA
Marketing start: 2022-03-10
Marketing end: 0000-00-00
Substance: POTASSIUM CHLORIDE
Active strength: 750 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3384	70518-3384-0	D	Discontinued by firm		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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3384	70518-3384-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3384	70518-3384-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3384	POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.]	3	Legacy NDC	20240316_b39640f1-c851-4f69-a280-4c6fdd97847b.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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3384-0	70518338400	100 POUCH in 1 BOX (70518-3384-0) > 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-3384-1)	100 pouch	2022-03-10	0000-00-00	No	No	Current