FDA.reportPublic FDA data

SODIUM CHLORIDE

Product NDC
77333-835
Requested package NDC
77333-835-10
11-digit product format
773330835
Labeler code
77333
Product ID
77333-835_eea3877b-0a59-11c2-e053-2995a90a7e68
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM CHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Gendose Pharmaceuticals, LLC
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-05-15
Marketing end
0000-00-00
Substance
SODIUM CHLORIDE
Active strength
1 g/1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage77333-83577333-835-10IInactivated by FDA2026-10-05

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77333-83577333-835-10IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77333-835-102024-05-02C16284748780-11030e365-6f5f-111a-e063-dadaa90a10e2GENDOSE - SODIUM CHLORIDE 1 GRAM TABLETS, USP (77333-835)
77333-835-102024-01-30C16284748780-11030e365-6f5f-111a-e063-dadaa90a10e2GENDOSE - SODIUM CHLORIDE 1 GRAM TABLETS, USP (77333-835)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-835-10SODIUM CHLORIDE1 GRAM100 in 1 BOXTABLET1004
77333-835-25SODIUM CHLORIDE1 GRAM1 in 1 BLISTER PACKTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-835-10EA - Each77333-835e538847d-2bd9-4c56-9469-6cfb485b5da912022-12-07
77333-835-25EA - Each77333-8356a86f719-06d3-4a3c-b1bb-3a3efde43db112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77333-835SODIUM CHLORIDE 1 GRAM (SODIUM CHLORIDE) TABLET [GENDOSE PHARMACEUTICALS, LLC]4Legacy NDC, 2 package rows20240504_ee8fcda0-b1c7-fb1c-e053-2995a90af7af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313009sodium chloride 1 GM Oral TabletPSNee8fcda0-b1c7-fb1c-e053-2995a90af7af4
313009sodium chloride 1000 MG Oral TabletSCDee8fcda0-b1c7-fb1c-e053-2995a90af7af4
313009NaCl 1000 MG Oral TabletSYee8fcda0-b1c7-fb1c-e053-2995a90af7af4
313009sodium chloride 0.124 MEQ/ML Oral SolutionSYee8fcda0-b1c7-fb1c-e053-2995a90af7af4
313009sodium chloride 0.171 MEQ/ML Oral SolutionSYee8fcda0-b1c7-fb1c-e053-2995a90af7af4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77333-835-1077333083510100 BLISTER PACK in 1 BOX (77333-835-10) > 1 TABLET in 1 BLISTER PACK (77333-835-25) 100 blister pack2020-05-150000-00-00NoNoCurrent