Sodium Chloride

Product NDC: 0404-9955
11-digit product format: 004049955
Labeler code: 0404
Product ID: 0404-9955_1e6c9f43-8251-45d9-979a-7de12ec9ad32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Chloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: ANDA088912
Marketing category: ANDA
Marketing start: 2022-01-12
Substance: SODIUM CHLORIDE
Active strength: 9 mg/mL
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 43.

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	Approval date
A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10
A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10
A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10
A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A088912-001	AP
A088912-002	AP
A088912-003	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 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 89 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A088912-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088912-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088912-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088912-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088912-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088912-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088912-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088912-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088912-003	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: Sodium Chloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM CHLORIDE	9 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1807637	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
e0466bb3-6c26-4044-b051-69f48b67f632	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
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
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
0404-9955-10	Sodium Chloride	1 in 1 BAG	INJECTION	1		6
0404-9955-10	Sodium Chloride	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION	10		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9955	SODIUM CHLORIDE INJECTION [HENRY SCHEIN, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240530_e0466bb3-6c26-4044-b051-69f48b67f632.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	Cardinal Health 107, LLC	97007188-43fe-416c-a87b-6ccc4d9ae2ec	2025-10-29	Adverse reactions	Exact identifier application applno (ANDA): 088912 application number: ANDA088912
Sodium Chloride	SODIUM CHLORIDE	Henry Schein, Inc.	e0466bb3-6c26-4044-b051-69f48b67f632	2025-08-07	Adverse reactions	Exact identifier application applno (ANDA): 088912 application number: ANDA088912 ndc (product): 0404-9955
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	f62481fd-fcdb-4be6-ac13-29c590e925c3	2022-02-10	Adverse reactions	Exact identifier application applno (ANDA): 088912 application number: ANDA088912

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
1807637	sodium chloride 0.9 % in 10 ML Injection	PSN	e0466bb3-6c26-4044-b051-69f48b67f632	6
1807637	10 ML sodium chloride 9 MG/ML Injection	SCD	e0466bb3-6c26-4044-b051-69f48b67f632	6
1807637	10 ML NaCl 9 MG/ML Injection	SY	e0466bb3-6c26-4044-b051-69f48b67f632	6
1807637	normal saline 10 mL Injection	SY	e0466bb3-6c26-4044-b051-69f48b67f632	6
1807637	sodium chloride 0.9 % per 10 ML Injection	SY	e0466bb3-6c26-4044-b051-69f48b67f632	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9955-10	00404995510	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9955-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2022-01-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
45764F/Revised: November 2020 SODIUM CHLORIDE INJECTION, USP 0.9%	Henry Schein, Inc.	2025-08-07	HUMAN PRESCRIPTION DRUG LABEL	6