Sodium chloride

Product NDC: 63323-626
11-digit product format: 633230626
Labeler code: 63323
Product ID: 63323-626_713303dd-2658-4037-8583-a12a38eb367b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM CHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA208122
Marketing category: ANDA
Marketing start: 2018-07-23
Substance: SODIUM CHLORIDE
Active strength: 450 mg/100mL
Pharmacologic classes: Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/100ML	INJECTABLE / INJECTION	AP		2018-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208122-001	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 2 · 41 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	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A208122-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208122-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208122-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208122-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208122-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208122-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208122-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208122-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208122-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208122-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208122-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208122-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208122-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208122-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208122-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208122-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208122-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208122-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208122-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208122-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208122-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208122-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208122-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208122-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208122-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208122-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208122-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208122-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208122-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208122-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208122-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208122-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208122-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208122-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208122-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208122-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208122-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208122-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208122-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208122-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sodium chloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM CHLORIDE	450 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
451W47IQ8X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1807548	Internal RxNorm lookup
1807549	Internal RxNorm lookup
1807550	Internal RxNorm lookup
1807551	Internal RxNorm lookup
1807552	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
83994d0c-8484-4505-abb5-8a384ed12288	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
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
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	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	SPL version
63323-626-00	Sodium chloride	50 in 1 CASE	INJECTION, SOLUTION	50	7
63323-626-01	Sodium chloride	50 mL in 1 BAG	INJECTION, SOLUTION	50	7
63323-626-02	Sodium chloride	100 mL in 1 BAG	INJECTION, SOLUTION	100	7
63323-626-03	Sodium chloride	250 mL in 1 BAG	INJECTION, SOLUTION	250	7
63323-626-04	Sodium chloride	500 mL in 1 BAG	INJECTION, SOLUTION	500	7
63323-626-05	Sodium chloride	1000 mL in 1 BAG	INJECTION, SOLUTION	1000	7
63323-626-10	Sodium chloride	10 in 1 CASE	INJECTION, SOLUTION	10	7
63323-626-25	Sodium chloride	30 in 1 CASE	INJECTION, SOLUTION	30	7
63323-626-50	Sodium chloride	60 in 1 CASE	INJECTION, SOLUTION	60	7
63323-626-55	Sodium chloride	20 in 1 CASE	INJECTION, SOLUTION	20	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-626-00	ML - Milliliter	63323-626	4b822173-1733-4366-9637-1168ee1668ce	1	2019-11-12
63323-626-01	ML - Milliliter	63323-626	353aa619-11bf-4238-86e1-d8be2d0538ce	1	2019-11-12
63323-626-02	ML - Milliliter	63323-626	3d1cdb2b-e6bb-475d-b6e8-8447d10028a0	1	2019-11-12
63323-626-03	ML - Milliliter	63323-626	1fa1cb66-fb2c-4cb1-b763-5866e855000a	1	2019-11-12
63323-626-04	ML - Milliliter	63323-626	e2fd9849-bc3e-4a2e-8bb8-0f05a2e8fe53	1	2019-11-12
63323-626-05	ML - Milliliter	63323-626	0d925879-72d5-4762-8510-db4216908fd8	1	2019-11-12
63323-626-10	ML - Milliliter	63323-626	d2c796f0-fa42-4bfd-9b4d-04a50fc20188	1	2019-11-12
63323-626-25	ML - Milliliter	63323-626	25f29fd1-0a13-41ac-9904-d9beda6407ab	1	2019-11-12
63323-626-50	ML - Milliliter	63323-626	decaba55-fc38-4182-ae87-9fd724e56c24	1	2019-11-12
63323-626-55	ML - Milliliter	63323-626	e405b344-c085-46f0-ac08-35150a6f4831	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-626	SODIUM CHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	7	Current NDC, Legacy NDC, 10 package rows	20240806_83994d0c-8484-4505-abb5-8a384ed12288.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	83994d0c-8484-4505-abb5-8a384ed12288	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208122 application number: ANDA208122 ndc (product): 63323-626
sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	8df7dcf6-8714-6caf-e053-2995a90ab8cc	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208122 application number: ANDA208122
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	239a5af1-7498-480f-862c-ab7c3d89d183	2024-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208122 application number: ANDA208122

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
451W47IQ8X	SODIUM CHLORIDE	7647-14-5	SODIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1807549	sodium chloride 0.45 % in 100 ML Injection	PSN	83994d0c-8484-4505-abb5-8a384ed12288	7
1807552	sodium chloride 0.45 % in 1000 ML Injection	PSN	83994d0c-8484-4505-abb5-8a384ed12288	7
1807550	sodium chloride 0.45 % in 250 ML Injection	PSN	83994d0c-8484-4505-abb5-8a384ed12288	7
1807548	sodium chloride 0.45 % in 50 ML Injection	PSN	83994d0c-8484-4505-abb5-8a384ed12288	7
1807551	sodium chloride 0.45 % in 500 ML Injection	PSN	83994d0c-8484-4505-abb5-8a384ed12288	7
1807549	100 ML sodium chloride 4.5 MG/ML Injection	SCD	83994d0c-8484-4505-abb5-8a384ed12288	7
1807552	1000 ML sodium chloride 4.5 MG/ML Injection	SCD	83994d0c-8484-4505-abb5-8a384ed12288	7
1807550	250 ML sodium chloride 4.5 MG/ML Injection	SCD	83994d0c-8484-4505-abb5-8a384ed12288	7
1807548	50 ML sodium chloride 4.5 MG/ML Injection	SCD	83994d0c-8484-4505-abb5-8a384ed12288	7
1807551	500 ML sodium chloride 4.5 MG/ML Injection	SCD	83994d0c-8484-4505-abb5-8a384ed12288	7
1807549	100 ML NaCl 4.5 MG/ML Injection	SY	83994d0c-8484-4505-abb5-8a384ed12288	7
1807552	1000 ML NaCl 4.5 MG/ML Injection	SY	83994d0c-8484-4505-abb5-8a384ed12288	7
1807550	250 ML NaCl 4.5 MG/ML Injection	SY	83994d0c-8484-4505-abb5-8a384ed12288	7
1807548	50 ML NaCl 4.5 MG/ML Injection	SY	83994d0c-8484-4505-abb5-8a384ed12288	7
1807551	500 ML NaCl 4.5 MG/ML Injection	SY	83994d0c-8484-4505-abb5-8a384ed12288	7
1807549	sodium chloride 0.45 % per 100 ML Injection	SY	83994d0c-8484-4505-abb5-8a384ed12288	7
1807552	sodium chloride 0.45 % per 1000 ML Injection	SY	83994d0c-8484-4505-abb5-8a384ed12288	7
1807550	sodium chloride 0.45 % per 250 ML Injection	SY	83994d0c-8484-4505-abb5-8a384ed12288	7
1807548	sodium chloride 0.45 % per 50 ML Injection	SY	83994d0c-8484-4505-abb5-8a384ed12288	7
1807551	sodium chloride 0.45 % per 500 ML Injection	SY	83994d0c-8484-4505-abb5-8a384ed12288	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-626-00	63323062600	50 BAG in 1 CASE (63323-626-00) / 100 mL in 1 BAG (63323-626-02)	50 bag	2018-07-23	0000-00-00	No	No	Current
63323-626-01	63323062601	50 mL in 1 BAG	50 ml					Historical
63323-626-02	63323062602	100 mL in 1 BAG	100 ml					Historical
63323-626-03	63323062603	250 mL in 1 BAG	250 ml					Historical
63323-626-04	63323062604	500 mL in 1 BAG	500 ml					Historical
63323-626-05	63323062605	1000 mL in 1 BAG	1000 ml					Historical
63323-626-10	63323062610	10 BAG in 1 CASE (63323-626-10) / 1000 mL in 1 BAG (63323-626-05)	10 bag	2018-07-23	0000-00-00	No	No	Current
63323-626-25	63323062625	30 BAG in 1 CASE (63323-626-25) / 250 mL in 1 BAG (63323-626-03)	30 bag	2018-07-23	0000-00-00	No	No	Current
63323-626-50	63323062650	60 BAG in 1 CASE (63323-626-50) / 50 mL in 1 BAG (63323-626-01)	60 bag	2018-07-23	0000-00-00	No	No	Current
63323-626-55	63323062655	20 BAG in 1 CASE (63323-626-55) / 500 mL in 1 BAG (63323-626-04)	20 bag	2018-07-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
0.45% Sodium Chloride Injection, USP	Fresenius Kabi USA, LLC \| Fresenius Kabi Deutschland GmbH \| HP Halden Pharma AS	2024-07-22	HUMAN PRESCRIPTION DRUG LABEL	7