Sodium Chloride

Product NDC
52584-888
Requested package NDC
52584-888-50
11-digit product format
525840888
Labeler code
52584
Product ID
52584-888_d1e5787a-3258-4229-92b5-84cc35012a78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
General Injectables & Vaccines, Inc
Application
NDA018803
Marketing category
NDA
Marketing start
2010-08-01
Marketing end
0000-00-00
Substance
SODIUM CHLORIDE
Active strength
9 mg/mL
Pharmacologic classes
Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52584-88852584-888-50DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018803-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE90MG/10ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29
N018803-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE180MG/20ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29
N018803-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29
N018803-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE18MG/2ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22
N018803-005SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE27MG/3ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22
N018803-006SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018803-001AP
N018803-002AP
N018803-003AP

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 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018803-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N018803-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER180MG/20ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N018803-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N018803-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER18MG/2ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22caaa826d4ba7…
2026-08-18 06:07:402026-07N018803-005SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER27MG/3ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22caaa826d4ba7…
2026-08-18 06:07:402026-07N018803-006SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018803-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018803-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER180MG/20ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018803-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018803-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER18MG/2ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018803-005SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER27MG/3ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018803-006SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018803-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018803-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER180MG/20ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018803-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018803-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER18MG/2ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018803-005SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER27MG/3ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018803-006SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018803-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018803-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER180MG/20ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018803-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018803-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER18MG/2ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018803-005SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER27MG/3ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018803-006SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018803-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018803-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER180MG/20ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018803-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018803-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER18MG/2ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018803-005SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER27MG/3ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018803-006SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018803-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018803-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER180MG/20ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018803-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018803-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER18MG/2ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018803-005SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER27MG/3ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018803-006SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018803-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018803-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER180MG/20ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018803-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS1982-10-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018803-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER18MG/2ML (9MG/ML)SOLUTION / INJECTIONRLD2015-01-2203ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018803-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N018803-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N018803-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018803-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018803-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018803-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018803-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018803-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018803-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018803-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018803-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018803-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018803-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018803-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018803-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018803-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018803-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018803-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018803-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018803-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018803-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018803-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018803-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018803-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018803-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018803-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018803-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018803-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018803-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018803-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018803-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018803-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018803-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018803-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018803-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018803-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018803-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018803-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018803-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018803-001AP11e350fbaab3a…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium ChlorideACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]6
Sodium CationACTIVE MOIETYLYR4M0NH37SODIUM CHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]6

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC107af8bc-b6af-4b85-8c8a-ea757dcef1da2026-06-12Adverse reactionsExact identifier
application applno (NDA): 018803
application number: NDA018803
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution48d73434-e65b-dc98-e063-6294a90affa22026-01-20Adverse reactionsExact identifier
application applno (NDA): 018803
application number: NDA018803
Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.d8b8d796-bfba-42af-a859-99d7768715582025-11-07Adverse reactionsExact identifier
application applno (NDA): 018803
application number: NDA018803
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst8dfb05c0-77e8-2fa1-e053-2a95a90a3d332025-01-08Adverse reactionsExact identifier
application applno (NDA): 018803
application number: NDA018803
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst998a2a47-5c79-2efd-e053-2995a90a8fac2025-01-08Adverse reactionsExact identifier
application applno (NDA): 018803
application number: NDA018803
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7da788fc-3481-527f-e053-2a91aa0af6ac2025-01-08Adverse reactionsExact identifier
application applno (NDA): 018803
application number: NDA018803
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.8eb172da-dcd4-4660-4a8f-ad44a14b4af72024-11-06Adverse reactionsExact identifier
application applno (NDA): 018803
application number: NDA018803
Sodium ChlorideSODIUM CHLORIDEMedical Purchasing Solutions, LLCc3f8e83c-4fb9-91da-e053-2a95a90abd632021-04-12Adverse reactionsExact identifier
application applno (NDA): 018803
application number: NDA018803
Sodium ChlorideSODIUM CHLORIDEAsclemed USA, Inc.a411c118-ef0e-4c42-9924-4a06ec690e942021-01-14Adverse reactionsExact identifier
application applno (NDA): 018803
application number: NDA018803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-888-50525840888501 VIAL, SINGLE-DOSE in 1 BAG (52584-888-50) > 50 mL in 1 VIAL, SINGLE-DOSE2016-09-140000-00-00NoNoCurrent