Potassium Chloride Extended-Release

Product NDC: 63304-076
11-digit product format: 633040076
Labeler code: 63304
Product ID: 63304-076_0e924cf6-53b8-28c4-e063-6294a90a4ac4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Chloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA076368
Marketing category: ANDA
Marketing start: 2019-11-20
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: 2026-12-31
Current FDA listing: Yes

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
A076368-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2004-08-18
A076368-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2019-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076368-001	AB1
A076368-002	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 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	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076368-001	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-08-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076368-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	2019-06-05	`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	A076368-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076368-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076368-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076368-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076368-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076368-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076368-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076368-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076368-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076368-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076368-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076368-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076368-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076368-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076368-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076368-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076368-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076368-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076368-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076368-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076368-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076368-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076368-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076368-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076368-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076368-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076368-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076368-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076368-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076368-002	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076368-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076368-002	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076368-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076368-002	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076368-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076368-002	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076368-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076368-002	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076368-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076368-002	AB1	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Potassium Chloride Extended-Release
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CHLORIDE	750 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
8ed8ea55-8b15-f718-e053-2a95a90a587a	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
63304-076-01	Potassium Chloride Extended-Release	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	6
63304-076-05	Potassium Chloride Extended-Release	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	6
63304-076-10	Potassium Chloride Extended-Release	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-076-01	EA - Each	63304-076	da9d1afe-6ead-453d-ba9a-7e229b7cc72e	1	2019-12-10
63304-076-05	EA - Each	63304-076	2fb65909-8c50-4b8f-9a91-d26c0f090e10	1	2019-12-10
63304-076-10	EA - Each	63304-076	6d96192b-8871-4d9c-99a3-489eb1af5175	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-076	POTASSIUM CHLORIDE EXTENDED-RELEASE (POTASSIUM CHLORIDE) TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6	Current NDC, Legacy NDC, 3 package rows	20240110_8ed8ea55-8b15-f718-e053-2a95a90a587a.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	REMEDYREPACK INC.	7ec22e8e-6643-44fe-804d-ca0b0b266663	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	ff44dcd5-b255-4d80-83ee-3c8f922c99eb	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride	POTASSIUM CHLORIDE	Major Pharmaceuticals	5c2e888c-2f1e-4d5a-a456-20774ca83302	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Major Pharmaceuticals	7d74652b-3513-4ebb-8b47-10b3603d04a7	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	2feda15e-f325-41fe-a442-41a8cc62b855	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	6fc9eef0-3dfc-4344-85c7-9f11d9b99b65	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	1b64b0c9-31a2-4ee7-8818-66de906ebeda	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride	POTASSIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	47a87fb6-5e61-41c9-b759-10f7c74a67ce	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	55747ef3-9437-4bdc-9ebd-a74d8e2de1cf	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	473369cb-3a9b-437c-b08e-8fb38034c507	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	863e6980-4a66-48a5-a14f-828a00480c93	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	American Health Packaging	8c12c5f8-5950-44e3-9473-a0b95187b43c	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	7427c29e-55c1-4c30-b091-058c8bec592f	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	80dd5de2-5066-472b-b1f8-88070a5c7388	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	b5a6b6f2-d073-4bd3-a66c-bf34ccabfe51	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Sun Pharmaceutical Industries, Inc.	8ed8ea55-8b15-f718-e053-2a95a90a587a	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368 ndc (product): 63304-076
Potassium Chloride	POTASSIUM CHLORIDE	Sun Pharmaceutical Industries, Inc.	0a1f2f64-3b0b-5e5c-e063-6294a90a7185	2023-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076368 application number: ANDA076368

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
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	863e6980-4a66-48a5-a14f-828a00480c93	106
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	863e6980-4a66-48a5-a14f-828a00480c93	106
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	863e6980-4a66-48a5-a14f-828a00480c93	106
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	863e6980-4a66-48a5-a14f-828a00480c93	106
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	863e6980-4a66-48a5-a14f-828a00480c93	106
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	863e6980-4a66-48a5-a14f-828a00480c93	106
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	b5a6b6f2-d073-4bd3-a66c-bf34ccabfe51	103
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	b5a6b6f2-d073-4bd3-a66c-bf34ccabfe51	103
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	b5a6b6f2-d073-4bd3-a66c-bf34ccabfe51	103
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	b5a6b6f2-d073-4bd3-a66c-bf34ccabfe51	103
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	b5a6b6f2-d073-4bd3-a66c-bf34ccabfe51	103
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	b5a6b6f2-d073-4bd3-a66c-bf34ccabfe51	103
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	1b64b0c9-31a2-4ee7-8818-66de906ebeda	100
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	6fc9eef0-3dfc-4344-85c7-9f11d9b99b65	100
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	ff44dcd5-b255-4d80-83ee-3c8f922c99eb	100
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	2feda15e-f325-41fe-a442-41a8cc62b855	100
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	2feda15e-f325-41fe-a442-41a8cc62b855	100
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	ff44dcd5-b255-4d80-83ee-3c8f922c99eb	100
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	1b64b0c9-31a2-4ee7-8818-66de906ebeda	100
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	6fc9eef0-3dfc-4344-85c7-9f11d9b99b65	100
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	2feda15e-f325-41fe-a442-41a8cc62b855	100
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	ff44dcd5-b255-4d80-83ee-3c8f922c99eb	100
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	1b64b0c9-31a2-4ee7-8818-66de906ebeda	100
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	6fc9eef0-3dfc-4344-85c7-9f11d9b99b65	100
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	ff44dcd5-b255-4d80-83ee-3c8f922c99eb	100
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	1b64b0c9-31a2-4ee7-8818-66de906ebeda	100
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	6fc9eef0-3dfc-4344-85c7-9f11d9b99b65	100
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	2feda15e-f325-41fe-a442-41a8cc62b855	100
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	6fc9eef0-3dfc-4344-85c7-9f11d9b99b65	100
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	ff44dcd5-b255-4d80-83ee-3c8f922c99eb	100
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	1b64b0c9-31a2-4ee7-8818-66de906ebeda	100
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	2feda15e-f325-41fe-a442-41a8cc62b855	100
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	1b64b0c9-31a2-4ee7-8818-66de906ebeda	100
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	6fc9eef0-3dfc-4344-85c7-9f11d9b99b65	100
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	2feda15e-f325-41fe-a442-41a8cc62b855	100
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	ff44dcd5-b255-4d80-83ee-3c8f922c99eb	100
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	7427c29e-55c1-4c30-b091-058c8bec592f	8
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	80dd5de2-5066-472b-b1f8-88070a5c7388	8
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	473369cb-3a9b-437c-b08e-8fb38034c507	8
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	80dd5de2-5066-472b-b1f8-88070a5c7388	8
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	473369cb-3a9b-437c-b08e-8fb38034c507	8
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	7427c29e-55c1-4c30-b091-058c8bec592f	8
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	7427c29e-55c1-4c30-b091-058c8bec592f	8
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	80dd5de2-5066-472b-b1f8-88070a5c7388	8
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	473369cb-3a9b-437c-b08e-8fb38034c507	8
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	473369cb-3a9b-437c-b08e-8fb38034c507	8
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	80dd5de2-5066-472b-b1f8-88070a5c7388	8
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	7427c29e-55c1-4c30-b091-058c8bec592f	8
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	473369cb-3a9b-437c-b08e-8fb38034c507	8
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	80dd5de2-5066-472b-b1f8-88070a5c7388	8
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	7427c29e-55c1-4c30-b091-058c8bec592f	8
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	473369cb-3a9b-437c-b08e-8fb38034c507	8
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	80dd5de2-5066-472b-b1f8-88070a5c7388	8
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	7427c29e-55c1-4c30-b091-058c8bec592f	8
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	55747ef3-9437-4bdc-9ebd-a74d8e2de1cf	7
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	55747ef3-9437-4bdc-9ebd-a74d8e2de1cf	7
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	55747ef3-9437-4bdc-9ebd-a74d8e2de1cf	7
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	55747ef3-9437-4bdc-9ebd-a74d8e2de1cf	7
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	55747ef3-9437-4bdc-9ebd-a74d8e2de1cf	7
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	55747ef3-9437-4bdc-9ebd-a74d8e2de1cf	7
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	8ed8ea55-8b15-f718-e053-2a95a90a587a	6
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	8ed8ea55-8b15-f718-e053-2a95a90a587a	6
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	8ed8ea55-8b15-f718-e053-2a95a90a587a	6
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	8ed8ea55-8b15-f718-e053-2a95a90a587a	6
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	8ed8ea55-8b15-f718-e053-2a95a90a587a	6
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	8ed8ea55-8b15-f718-e053-2a95a90a587a	6
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	7ec22e8e-6643-44fe-804d-ca0b0b266663	5
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	7ec22e8e-6643-44fe-804d-ca0b0b266663	5
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	7ec22e8e-6643-44fe-804d-ca0b0b266663	5
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	7ec22e8e-6643-44fe-804d-ca0b0b266663	5
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	7ec22e8e-6643-44fe-804d-ca0b0b266663	5
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	7ec22e8e-6643-44fe-804d-ca0b0b266663	5
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	8c12c5f8-5950-44e3-9473-a0b95187b43c	2
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	8c12c5f8-5950-44e3-9473-a0b95187b43c	2
1801298	Microencapsulated K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	8c12c5f8-5950-44e3-9473-a0b95187b43c	2
1801298	Microencapsulated Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	8c12c5f8-5950-44e3-9473-a0b95187b43c	2
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	SY	8c12c5f8-5950-44e3-9473-a0b95187b43c	2
1801298	potassium chloride 750 MG Microencapsulated Extended Release Oral	SY	8c12c5f8-5950-44e3-9473-a0b95187b43c	2
1801298	potassium chloride 10 MEQ Microencapsulated Extended Release Oral Tablet	PSN	7d74652b-3513-4ebb-8b47-10b3603d04a7	1
1801298	Microencapsulated potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	7d74652b-3513-4ebb-8b47-10b3603d04a7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-076-01	63304007601	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-076-01)	2019-11-20	0000-00-00	No	No	Current
63304-076-05	63304007605	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-076-05)	2019-11-20	0000-00-00	No	No	Current
63304-076-10	63304007610	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-076-10)	2019-11-20	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 K	REMEDYREPACK INC.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	6
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS, USP 10 mEq K	Bryant Ranch Prepack	2026-03-11	HUMAN PRESCRIPTION DRUG LABEL	100
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS, USP 10 mEq K	Major Pharmaceuticals	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	1
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS, USP 10 mEq K	Bryant Ranch Prepack	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	100
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS, USP 10 mEq K	Bryant Ranch Prepack	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	100
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS, USP 10 mEq K	Bryant Ranch Prepack	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	100
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS, USP 10 mEq K	Bryant Ranch Prepack	2024-10-29	HUMAN PRESCRIPTION DRUG LABEL	7
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS, USP 10 mEq K	Bryant Ranch Prepack	2024-10-03	HUMAN PRESCRIPTION DRUG LABEL	8
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS, USP 10 mEq K	Bryant Ranch Prepack	2024-08-23	HUMAN PRESCRIPTION DRUG LABEL	106
Potassium Chloride Extended-Release Tablets, USP 8463201/1021 Rx only	American Health Packaging	2024-08-22	HUMAN PRESCRIPTION DRUG LABEL	2
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS, USP 10 mEq K	Bryant Ranch Prepack	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	8
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS, USP 10 mEq K	Bryant Ranch Prepack	2024-08-05	HUMAN PRESCRIPTION DRUG LABEL	8
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS, USP 10 mEq K	Bryant Ranch Prepack	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	103
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS, USP 10 mEq K	Sun Pharmaceutical Industries, Inc. \| Adare Pharmaceuticals, Inc.	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	6