Potassium Chloride

Product NDC: 0378-4560
11-digit product format: 003784560
Labeler code: 0378
Product ID: 0378-4560_a05e4397-8442-41d9-afa7-832163c3b554
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: potassium chloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA204662
Marketing category: ANDA
Marketing start: 2016-11-09
Marketing end: 2026-12-31
Substance: POTASSIUM CHLORIDE
Active strength: 8 meq/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
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
excluded package	package	0378-4560	0378-4560-05	D	Discontinued by firm		2026-08-11

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
A204662-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2014-08-21
A204662-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2		2014-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204662-001	AB2
A204662-002	AB2

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	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204662-001	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204662-002	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-08-21	`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	A204662-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204662-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204662-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204662-002	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204662-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204662-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204662-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204662-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204662-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204662-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204662-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204662-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204662-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204662-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204662-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204662-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204662-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204662-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204662-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204662-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204662-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204662-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204662-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204662-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204662-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204662-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204662-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204662-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204662-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204662-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204662-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204662-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204662-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204662-002	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204662-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204662-002	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204662-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204662-002	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204662-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204662-002	AB2	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Potassium Chloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CHLORIDE	8 meq/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
312529	Internal RxNorm lookup
628953	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
c64ed4c0-1e27-42b3-9625-fb4e0d31e271	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-4560-05	Potassium Chloride	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	500		11
0378-4560-77	Potassium Chloride	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	90		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-4560-05	EA - Each	0378-4560	ca4b1224-7516-4828-b668-43cfe7f772e7	1	2014-09-03
0378-4560-77	EA - Each	0378-4560	314f6229-0786-4cfa-b368-240eb82f5ebb	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-4560	POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	11	Current NDC, Legacy NDC, 2 package rows	20250501_c64ed4c0-1e27-42b3-9625-fb4e0d31e271.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	f1af7e05-68ba-438e-a63b-cd8c23960c85	2023-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204662 application number: ANDA204662
Potassium Chloride	POTASSIUM CHLORIDE	Mylan Pharmaceuticals Inc.	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	2020-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204662 application number: ANDA204662 ndc (product): 0378-4560

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
628953	potassium chloride 10 MEQ (750 MG) Extended Release Oral Tablet	PSN	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	11
312529	potassium chloride 8 MEQ (600 MG) Extended Release Oral Tablet	PSN	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	11
628953	potassium chloride 10 MEQ Extended Release Oral Tablet	SCD	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	11
312529	potassium chloride 8 MEQ Extended Release Oral Tablet	SCD	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	11
628953	K+ Chloride 10 MEQ Extended Release Oral Tablet	SY	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	11
312529	K+ Chloride 8 MEQ Extended Release Oral Tablet	SY	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	11
628953	Pot Chloride 10 MEQ Extended Release Oral Tablet	SY	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	11
312529	Pot Chloride 8 MEQ Extended Release Oral Tablet	SY	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	11
312529	potassium chloride 600 MG Extended Release Oral Tablet	SY	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	11
628953	potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral Tablet	SY	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	11
628953	potassium chloride 750 MG Extended Release Oral Tablet	SY	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-4560-05	00378456005	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4560-05)	2016-11-09	2026-06-30	No	No	Current
0378-4560-77	00378456077	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4560-77)	2016-11-09	2026-12-31	No	No	Current