Potassium Chloride

Product NDC: 63323-667
Requested package NDC: 63323-667-10
11-digit product format: 633230667
Labeler code: 63323
Product ID: 63323-667_fa0a4b99-d041-42d8-843d-e7dbead01d89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Chloride, Dextrose Monohydrate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA212346
Marketing category: ANDA
Marketing start: 2021-04-23
Substance: DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE
Active strength: 5; 75 g/100mL; mg/100mL
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
A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	DEXTROSE; POTASSIUM CHLORIDE	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP		2020-09-10
A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	DEXTROSE; POTASSIUM CHLORIDE	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP		2020-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212346-001	AP
A212346-002	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 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
2026-02-19 14:30 UTC	2026-02	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	2020-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION		2020-09-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION		2020-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION		2020-09-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION		2020-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION		2020-09-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION		2020-09-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION		2020-09-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION		2020-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION		2020-09-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION		2020-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212346-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION		2020-09-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212346-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION		2020-09-10	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	A212346-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212346-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212346-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212346-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212346-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212346-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212346-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212346-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212346-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212346-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212346-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212346-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212346-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212346-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212346-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212346-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212346-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212346-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212346-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212346-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212346-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212346-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212346-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212346-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212346-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212346-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212346-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212346-002	AP	1	`8072bd15b7f6…`
2021-03-12 10:30 UTC	2021-03	A212346-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A212346-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212346-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A212346-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212346-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A212346-002	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212346-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212346-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212346-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212346-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212346-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212346-002	AP	1	`ea1830bbd6c7…`

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	5 g/100mL
DEXTROSE MONOHYDRATE	75 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LX22YL083G	Internal UNII lookup
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
309783	Internal RxNorm lookup
2566844	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
55d9ae37-4553-47e7-a2e3-86b48b5227cd	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
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
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
684ea482-2e8b-14af-5664-b98f1e402036	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
b060cc1a-fe47-856b-0b77-4448b5963de8	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
63323-667-01	Potassium Chloride	1000 mL in 1 BAG	INJECTION, SOLUTION	1000		4
63323-667-10	Potassium Chloride	10 in 1 CASE	INJECTION, SOLUTION	10		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-667-01	ML - Milliliter	63323-667	2c77f3db-1f1e-4f40-a367-77efebfa5042	1	2022-11-07
63323-667-10	ML - Milliliter	63323-667	5b7a13ad-ab62-4086-af67-114d22ba5bd6	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-667	POTASSIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20240511_55d9ae37-4553-47e7-a2e3-86b48b5227cd.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE	Fresenius Kabi USA, LLC	55d9ae37-4553-47e7-a2e3-86b48b5227cd	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212346 application number: ANDA212346 ndc (package): 63323-667-10 ndc (product): 63323-667 ndc11 (package): 63323066710

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LX22YL083G	DEXTROSE MONOHYDRATE	77938-63-7	DEXTROSE MONOHYDRATE
660YQ98I10	POTASSIUM CHLORIDE	7447-40-7	POTASSIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2566844	potassium chloride 10 MEQ / dextrose 5 % in 1000 ML Injection	PSN	55d9ae37-4553-47e7-a2e3-86b48b5227cd	4
309783	potassium chloride 20 MEQ / glucose 5 % in 1000 ML Injection	PSN	55d9ae37-4553-47e7-a2e3-86b48b5227cd	4
2566844	1000 ML dextrose monohydrate 50 MG/ML / potassium chloride 0.01 MEQ/ML Injection	SCD	55d9ae37-4553-47e7-a2e3-86b48b5227cd	4
309783	1000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML Injection	SCD	55d9ae37-4553-47e7-a2e3-86b48b5227cd	4
2566844	1000 ML dextrose monohydrate 50 MG/ML / K+ chloride 0.01 MEQ/ML Injection	SY	55d9ae37-4553-47e7-a2e3-86b48b5227cd	4
2566844	1000 ML dextrose monohydrate 50 MG/ML / Pot chloride 0.01 MEQ/ML Injection	SY	55d9ae37-4553-47e7-a2e3-86b48b5227cd	4
309783	1000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML Injection	SY	55d9ae37-4553-47e7-a2e3-86b48b5227cd	4
309783	1000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML Injection	SY	55d9ae37-4553-47e7-a2e3-86b48b5227cd	4
309783	dextrose 5 % / potassium chloride 20 MEQ per 1000 ML Injection	SY	55d9ae37-4553-47e7-a2e3-86b48b5227cd	4
2566844	potassium chloride 10 MEQ / dextrose 5 % per 1000 ML Injection	SY	55d9ae37-4553-47e7-a2e3-86b48b5227cd	4
309783	potassium chloride 20 MEQ / dextrose 5 % per 1000 ML Injection	SY	55d9ae37-4553-47e7-a2e3-86b48b5227cd	4
309783	potassium chloride 20 MEQ / glucose 5 % per 1000 ML Injection	SY	55d9ae37-4553-47e7-a2e3-86b48b5227cd	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-667-10	63323066710	10 BAG in 1 CASE (63323-667-10) / 1000 mL in 1 BAG (63323-667-01)	10 bag	2021-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Potassium Chloride	Fresenius Kabi USA, LLC \| HP Halden Pharma AS	2024-05-08	HUMAN PRESCRIPTION DRUG LABEL	4