Potassium Chloride Extended-release

Product NDC: 70010-135
11-digit product format: 700100135
Labeler code: 70010
Product ID: 70010-135_495d2e0b-e6b6-958e-e063-6394a90ac328
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Chloride Extended-release
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA214452
Marketing category: ANDA
Marketing start: 2021-01-30
Substance: POTASSIUM CHLORIDE
Active strength: 1500 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A214452-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2020-10-21
A214452-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2020-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214452-001	AB1
A214452-002	AB1

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 2 · 74 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
2026-08-18 06:07:40	2026-07	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214452-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214452-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2020-10-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214452-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214452-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214452-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214452-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214452-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214452-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214452-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214452-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214452-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214452-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214452-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214452-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214452-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214452-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214452-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214452-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214452-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214452-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214452-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214452-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214452-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214452-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214452-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214452-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214452-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214452-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214452-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214452-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214452-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214452-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214452-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214452-002	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214452-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214452-002	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214452-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214452-002	AB1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214452-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214452-002	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214452-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214452-002	AB1	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Potassium Chloride Extended-release
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CHLORIDE	1500 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
1801294	Internal RxNorm lookup
1801298	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
b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	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
70010-135-01	Potassium Chloride Extended-release	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	8
70010-135-05	Potassium Chloride Extended-release	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	8
70010-135-10	Potassium Chloride Extended-release	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-135-01	EA - Each	70010-135	0e3c8490-d3bf-41a9-8b91-37cc89c2f4e1	1	2021-04-08
70010-135-05	EA - Each	70010-135	ece152fc-5417-4497-9878-ba67b5a1a3fb	1	2021-04-08
70010-135-10	EA - Each	70010-135	00f2046d-933a-4c8a-bce8-ebc28d0658ec	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-135	POTASSIUM CHLORIDE EXTENDED-RELEASE TABLET, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 3 package rows	20240125_b3d4d5b5-2898-ae3d-e053-2a95a90a6d04.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	REMEDYREPACK INC.	2c407aaf-5d95-49ff-a5db-f1d7b5190334	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	Redpharm Drug	37455920-e408-5906-e063-6294a90a57ae	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	Atlantic Biologicals Corp.	4d7ad5c6-2c18-dc29-e063-6394a90a621e	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	REMEDYREPACK INC.	ace1eb11-b925-405a-b772-58c60b3ca7d4	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	Granules India Ltd	60285a8d-bcb0-40ba-b359-df5c89480cd6	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride ER	POTASSIUM CHLORIDE ER	Direct_Rx	42c92fcc-21d2-d32a-e063-6294a90a8312	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	Bluepoint Laboratories	d605ca36-2bfa-42cb-a46c-8ecb3162994e	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	A-S Medication Solutions	de335131-bb8a-44e5-89fa-1478edbcdc0e	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	A-S Medication Solutions	edb6c987-e2c3-421f-8a8d-849c9e17ace8	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	Granules Pharmaceuticals Inc.	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452 ndc (product): 70010-135
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	Preferred Pharmaceuticals Inc.	87f369cf-40e5-4f91-aa42-ae986fce6544	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride ER	POTASSIUM CHLORIDE ER	Direct_Rx	377854ff-8034-c7ac-e063-6294a90a0817	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE EXTENDED-RELEASE	NCS HealthCare of KY, LLC dba Vangard Labs	c684758c-16f0-4bd9-b719-1aae64b7907f	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	Proficient Rx LP	f191b15c-7959-4aa6-a2ef-617cde77c918	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	Bryant Ranch Prepack	b5505a39-57f1-4ed5-b845-4f1d8aa10950	2024-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	Bryant Ranch Prepack	7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	Proficient Rx LP	c53d1db5-1c9e-4289-a2a2-961e0dd56f32	2024-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214452 application number: ANDA214452

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
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb	102
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb	102
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb	102
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb	102
1801294	potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet	SY	7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb	102
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	SY	7b8e7a4f-0d44-46b2-9565-7b4c294e9fcb	102
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	c684758c-16f0-4bd9-b719-1aae64b7907f	18
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	c684758c-16f0-4bd9-b719-1aae64b7907f	18
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	c684758c-16f0-4bd9-b719-1aae64b7907f	18
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	c684758c-16f0-4bd9-b719-1aae64b7907f	18
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	c684758c-16f0-4bd9-b719-1aae64b7907f	18
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	c684758c-16f0-4bd9-b719-1aae64b7907f	18
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	c684758c-16f0-4bd9-b719-1aae64b7907f	18
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	c684758c-16f0-4bd9-b719-1aae64b7907f	18
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	c684758c-16f0-4bd9-b719-1aae64b7907f	18
1801294	potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet	SY	c684758c-16f0-4bd9-b719-1aae64b7907f	18
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	SY	c684758c-16f0-4bd9-b719-1aae64b7907f	18
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	c684758c-16f0-4bd9-b719-1aae64b7907f	18
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	8
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	8
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	8
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	8
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	8
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	8
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	8
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	8
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	8
1801294	potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet	SY	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	8
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	SY	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	8
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	8
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	de335131-bb8a-44e5-89fa-1478edbcdc0e	6
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	edb6c987-e2c3-421f-8a8d-849c9e17ace8	6
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	de335131-bb8a-44e5-89fa-1478edbcdc0e	6
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	edb6c987-e2c3-421f-8a8d-849c9e17ace8	6
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	de335131-bb8a-44e5-89fa-1478edbcdc0e	6
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	edb6c987-e2c3-421f-8a8d-849c9e17ace8	6
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	edb6c987-e2c3-421f-8a8d-849c9e17ace8	6
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	de335131-bb8a-44e5-89fa-1478edbcdc0e	6
1801294	potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet	SY	edb6c987-e2c3-421f-8a8d-849c9e17ace8	6
1801294	potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet	SY	de335131-bb8a-44e5-89fa-1478edbcdc0e	6
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	SY	edb6c987-e2c3-421f-8a8d-849c9e17ace8	6
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	SY	de335131-bb8a-44e5-89fa-1478edbcdc0e	6
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	37455920-e408-5906-e063-6294a90a57ae	4
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	87f369cf-40e5-4f91-aa42-ae986fce6544	4
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	87f369cf-40e5-4f91-aa42-ae986fce6544	4
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	37455920-e408-5906-e063-6294a90a57ae	4
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	87f369cf-40e5-4f91-aa42-ae986fce6544	4
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	37455920-e408-5906-e063-6294a90a57ae	4
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	87f369cf-40e5-4f91-aa42-ae986fce6544	4
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	37455920-e408-5906-e063-6294a90a57ae	4
1801294	potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet	SY	87f369cf-40e5-4f91-aa42-ae986fce6544	4
1801294	potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet	SY	37455920-e408-5906-e063-6294a90a57ae	4
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	SY	87f369cf-40e5-4f91-aa42-ae986fce6544	4
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	SY	37455920-e408-5906-e063-6294a90a57ae	4
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	ace1eb11-b925-405a-b772-58c60b3ca7d4	3
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	ace1eb11-b925-405a-b772-58c60b3ca7d4	3
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	ace1eb11-b925-405a-b772-58c60b3ca7d4	3
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	ace1eb11-b925-405a-b772-58c60b3ca7d4	3
1801294	potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet	SY	ace1eb11-b925-405a-b772-58c60b3ca7d4	3
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	SY	ace1eb11-b925-405a-b772-58c60b3ca7d4	3
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	f191b15c-7959-4aa6-a2ef-617cde77c918	2
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	4d7ad5c6-2c18-dc29-e063-6394a90a621e	2
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	4d7ad5c6-2c18-dc29-e063-6394a90a621e	2
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	f191b15c-7959-4aa6-a2ef-617cde77c918	2
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	4d7ad5c6-2c18-dc29-e063-6394a90a621e	2
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	f191b15c-7959-4aa6-a2ef-617cde77c918	2
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	4d7ad5c6-2c18-dc29-e063-6394a90a621e	2
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	f191b15c-7959-4aa6-a2ef-617cde77c918	2
1801294	potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet	SY	4d7ad5c6-2c18-dc29-e063-6394a90a621e	2
1801294	potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet	SY	f191b15c-7959-4aa6-a2ef-617cde77c918	2
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	SY	4d7ad5c6-2c18-dc29-e063-6394a90a621e	2
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	SY	f191b15c-7959-4aa6-a2ef-617cde77c918	2
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	28d89ce5-0df3-806f-e063-6394a90a02a7	1
1801294	potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet	PSN	377854ff-8034-c7ac-e063-6294a90a0817	1
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	28d89ce5-0df3-806f-e063-6394a90a02a7	1
1801294	Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet	SCD	377854ff-8034-c7ac-e063-6294a90a0817	1
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	28d89ce5-0df3-806f-e063-6394a90a02a7	1
1801294	Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet	SY	377854ff-8034-c7ac-e063-6294a90a0817	1
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	28d89ce5-0df3-806f-e063-6394a90a02a7	1
1801294	Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet	SY	377854ff-8034-c7ac-e063-6294a90a0817	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70010-135-01	70010013501	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-135-01)	2021-01-30	0000-00-00	No	No	Current
70010-135-05	70010013505	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-135-05)	2021-01-30	0000-00-00	No	No	Current
70010-135-10	70010013510	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-135-10)	2021-01-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Potassium Chloride Extended-Release Tablets USP, 10 mEq and 20 mEq Rx only	Redpharm Drug	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	4
Potassium Chloride Extended-Release Tablets USP, 20 mEq Rx only	Atlantic Biologicals Corp.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	2
Potassium Chloride Extended-Release Tablets USP, 10 mEq and 20 mEq Rx only	Granules Pharmaceuticals Inc. \| Granules India Ltd	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	7
Potassium Chloride Extended-Release Tablets USP, 10 mEq and 20 mEq Rx only	REMEDYREPACK INC.	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	3
Potassium Chloride Extended-Release Tablets USP, 10 mEq and 20 mEq Rx only	A-S Medication Solutions	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	6
Potassium Chloride Extended-Release Tablets USP, 10 mEq and 20 mEq Rx only	A-S Medication Solutions	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	6
Potassium Chloride Extended-Release Tablets USP, 10 mEq and 20 mEq Rx only	Preferred Pharmaceuticals Inc.	2025-09-10	HUMAN PRESCRIPTION DRUG LABEL	4
Potassium Chloride ER	Direct_Rx	2025-06-13	HUMAN PRESCRIPTION DRUG LABEL	1
Potassium Chloride Extended-Release Tablets, USP Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2025-01-16	HUMAN PRESCRIPTION DRUG LABEL	18
Potassium Chloride Extended-Release Tablets USP, 10 mEq and 20 mEq Rx only	Coupler LLC	2024-12-09	HUMAN PRESCRIPTION DRUG LABEL	1
Potassium Chloride Extended-Release Tablets USP, 20 mEq Rx only	Proficient Rx LP	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	2
Potassium Chloride Extended-Release Tablets USP, 10 mEq and 20 mEq Rx only	Bryant Ranch Prepack	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	102
Potassium Chloride Extended-Release Tablets USP, 10 mEq and 20 mEq Rx only	REMEDYREPACK INC.	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	3
Potassium Chloride Extended-Release Tablets USP, 10 mEq and 20 mEq Rx only	Major Pharmaceuticals	2022-03-29	HUMAN PRESCRIPTION DRUG LABEL	1