SODIUM CHLORIDE

Product NDC: 0019-1188
11-digit product format: 000191188
Labeler code: 0019
Product ID: 0019-1188_cdff7813-7b00-4f61-a017-18ab8910d49d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sodium chloride
Dosage form: INJECTION
Route: INTRAVASCULAR
Labeler: Liebel-Flarsheim Company LLC
Application: NDA021569
Marketing category: NDA
Marketing start: 2012-09-01
Substance: SODIUM CHLORIDE
Active strength: .9 mg/mL
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 42.

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
N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION		RLD	2006-07-27
N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION		RLD	2006-07-27

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	405MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1012.5MG/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	405MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1012.5MG/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	405MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1012.5MG/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	405MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1012.5MG/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	405MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1012.5MG/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`bb7c543d1eb4…`

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e4540d03-06b4-4b4d-b859-75c13e5c20dd	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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
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
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
0019-1188-27	SODIUM CHLORIDE	20 in 1 CARTON	INJECTION	20	16
0019-1188-27	SODIUM CHLORIDE	1 in 1 BOX	INJECTION	1	16
0019-1188-81	SODIUM CHLORIDE	20 in 1 CARTON	INJECTION	20	16
0019-1188-81	SODIUM CHLORIDE	1 in 1 BOX	INJECTION	1	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0019-1188-27	ML - Milliliter	0019-1188	6335fb0a-ad2e-43cf-8a6f-fec62d1d9595	1	2019-04-11
0019-1188-75	ML - Milliliter	0019-1188	593d5e77-f43a-4242-9252-f717ab33f250	1	2013-02-13
0019-1188-81	ML - Milliliter	0019-1188	0702b5e5-f3ba-4a36-8f2a-48a0fef9b891	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	SODIUM CHLORIDE INJECTION [MALLINCKRODT INC.]	7
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	SODIUM CHLORIDE INJECTION [MALLINCKRODT INC.]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	SODIUM CHLORIDE INJECTION [MALLINCKRODT INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0019-1188	SODIUM CHLORIDE INJECTION [LIEBEL-FLARSHEIM COMPANY LLC]	16	Current NDC, Legacy NDC, 4 package rows	20221228_e4540d03-06b4-4b4d-b859-75c13e5c20dd.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
SODIUM CHLORIDE	SODIUM CHLORIDE	Liebel-Flarsheim Company LLC	e4540d03-06b4-4b4d-b859-75c13e5c20dd	2022-12-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021569 application number: NDA021569 ndc (product): 0019-1188

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0019-1188-27	00019118827	20 BOX in 1 CARTON (0019-1188-27) / 1 SYRINGE, PLASTIC in 1 BOX / 125 mL in 1 SYRINGE, PLASTIC	20 box	2012-09-01	0000-00-00	No	No	Current
0019-1188-81	00019118881	20 BOX in 1 CARTON (0019-1188-81) / 1 SYRINGE, PLASTIC in 1 BOX / 125 mL in 1 SYRINGE, PLASTIC	20 box	2012-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SODIUM CHLORIDE	Liebel-Flarsheim Company LLC \| Avantor Performance Materials, Inc.	2022-12-20	HUMAN PRESCRIPTION DRUG LABEL	16