SODIUM CHLORIDE

Product NDC
0338-9537
11-digit product format
003389537
Labeler code
0338
Product ID
0338-9537_2830c05a-fc95-4057-9347-61fb6df7aa42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA016677
Marketing category
NDA
Marketing start
1970-12-09
Marketing end
0000-00-00
Substance
SODIUM CHLORIDE
Active strength
900 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
2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0338-9537DDiscontinued by firm2026-08-17
excluded productproduct0338-9537DDiscontinued by firm2026-08-17
excluded packagepackage0338-95370338-9537-50DDiscontinued by firm2026-08-17
excluded packagepackage0338-95370338-9537-50DDiscontinued 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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0338-9537-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0338-9537-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0338-9537-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0338-9537-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0338-9537-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0338-9537-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0338-9537-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0338-9537-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0338-9537-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0338-9537-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0338-9537-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0338-9537-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0338-9537-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0338-9537-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0338-9537-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0338-9537-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0338-9537-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0338-9537-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0338-9537-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0338-9537-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0338-9537-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0338-9537-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0338-9537-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0338-9537-50557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982
N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982
N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N016677-001AP
N016677-003AP

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 3 · 106 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N016677-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016677-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016677-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016677-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016677-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016677-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N016677-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016677-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016677-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016677-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016677-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016677-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016677-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016677-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016677-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016677-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016677-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016677-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016677-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016677-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016677-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N016677-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016677-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016677-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016677-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016677-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016677-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016677-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016677-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N016677-003AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016677-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016677-004AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016677-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N016677-004AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016677-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N016677-004AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016677-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N016677-004AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016677-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N016677-004AP1bb7c543d1eb4…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 016677
application number: NDA016677
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution3f79fb8b-d0e8-db2a-e063-6394a90ac1362025-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 016677
application number: NDA016677
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation958d35f0-6834-43be-a700-fa58f38b4c192025-06-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 016677
application number: NDA016677
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationf55bd888-5e01-474d-871b-24654c0701782024-07-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 016677
application number: NDA016677

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-9537-500033895375050 BAG in 1 CARTON (0338-9537-50) > 100 mL in 1 BAG50 bag2018-03-090000-00-00NoNoCurrent