Potassium Chloride

Product NDC: 0404-9937
11-digit product format: 004049937
Labeler code: 0404
Product ID: 0404-9937_b10f2db5-f661-422e-b335-a9c2914aa69d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Chloride
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: ANDA080205
Marketing category: ANDA
Marketing start: 2022-01-13
Substance: POTASSIUM CHLORIDE
Active strength: 149 mg/mL
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 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
A080205-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
A080205-003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982
A080205-004	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982
A080205-005	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A080205-001	AP

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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A080205-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080205-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080205-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080205-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CHLORIDE	149 mg/mL

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
1860136	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
8367a2ae-dfd9-4515-838c-529920291ca0	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
0404-9937-10	Potassium Chloride	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	1		7
0404-9937-10	Potassium Chloride	1 in 1 BAG	INJECTION, SOLUTION, CONCENTRATE	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9937	POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [HENRY SCHEIN, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20240518_8367a2ae-dfd9-4515-838c-529920291ca0.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	559a0a8c-a8fe-40a5-b196-21f9308780ab	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080205 application number: ANDA080205
Potassium Chloride	POTASSIUM CHLORIDE	Henry Schein, Inc.	8367a2ae-dfd9-4515-838c-529920291ca0	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080205 application number: ANDA080205 ndc (product): 0404-9937
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9508355e-e1ed-412b-e053-2a95a90aac8e	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080205 application number: ANDA080205
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	951ffdc3-d54f-d5e1-e053-2a95a90a79e6	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080205 application number: ANDA080205

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
1860136	potassium chloride 20 MEQ in 10 ML Injection	PSN	8367a2ae-dfd9-4515-838c-529920291ca0	7
1860136	10 ML potassium chloride 2 MEQ/ML Injection	SCD	8367a2ae-dfd9-4515-838c-529920291ca0	7
1860136	10 ML K+ Chloride 2 MEQ/ML Injection	SY	8367a2ae-dfd9-4515-838c-529920291ca0	7
1860136	10 ML Pot Chloride 2 MEQ/ML Injection	SY	8367a2ae-dfd9-4515-838c-529920291ca0	7
1860136	potassium chloride 14.9 % per 10 ML Injection	SY	8367a2ae-dfd9-4515-838c-529920291ca0	7
1860136	potassium chloride 20 MEQ per 10 ML Injection	SY	8367a2ae-dfd9-4515-838c-529920291ca0	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9937-10	00404993710	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9937-10) / 1 mL in 1 VIAL, SINGLE-DOSE	2022-01-13	0000-00-00	No	No	Current