Emetrol Powder

Product NDC
65197-203
11-digit product format
651970203
Labeler code
65197
Product ID
65197-203_a6121b17-e850-4677-9ad1-ceb36de16336
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Citrate Dihydrate
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
WellSpring Pharmaceutical Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-12-01
Substance
TRISODIUM CITRATE DIHYDRATE
Active strength
460 mg/1
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Emetrol Powder
Brand name suffix
Non-Drowsy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRISODIUM CITRATE DIHYDRATE460 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB22547B95K
Rxcui2671573, 2671579

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-203-09Emetrol PowderNon-Drowsy6 in 1 CARTONPOWDER, FOR SOLUTION63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-203EMETROL POWDER NON-DROWSY (SODIUM CITRATE DIHYDRATE) POWDER, FOR SOLUTION [WELLSPRING PHARMACEUTICAL CORPORATION]3Current NDC, 1 package rows20250110_9d8d2ee7-9db7-4be7-8c73-511eb2e32459.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2671579Emetrol Powder 460 MG Powder for Oral SolutionPSN9d8d2ee7-9db7-4be7-8c73-511eb2e324593
2671573sodium citrate 460 MG Powder for Oral SolutionPSN9d8d2ee7-9db7-4be7-8c73-511eb2e324593
2671579sodium citrate 460 MG Powder for Oral Solution [Emetrol Powder]SBD9d8d2ee7-9db7-4be7-8c73-511eb2e324593
2671573sodium citrate 460 MG Powder for Oral SolutionSCD9d8d2ee7-9db7-4be7-8c73-511eb2e324593
2671579Emetrol Powder 460 MG Powder for Oral SolutionSY9d8d2ee7-9db7-4be7-8c73-511eb2e324593
2671573sodium citrate 460 MG Powder for Oral SolutionSY9d8d2ee7-9db7-4be7-8c73-511eb2e324593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65197-203-09651970203096 POWDER, FOR SOLUTION in 1 CARTON (65197-203-09) 2023-12-01NoNoCurrent