Emetrol Chewables Mixed Berry

Product NDC
65197-420
11-digit product format
651970420
Labeler code
65197
Product ID
65197-420_35e7ffe9-370b-4d46-8019-737ca7238cc6
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium citrate dihydrate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
WellSpring Pharmaceutical Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-07-01
Substance
TRISODIUM CITRATE DIHYDRATE
Active strength
230 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 Chewables Mixed Berry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRISODIUM CITRATE DIHYDRATE230 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB22547B95K
Rxcui2002800, 2596185

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-420-60Emetrol Chewables Mixed Berry60 in 1 BOTTLETABLET, CHEWABLE602
65197-420-60Emetrol Chewables Mixed Berry1 in 1 BOXTABLET, CHEWABLE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-420EMETROL CHEWABLES MIXED BERRY (SODIUM CITRATE DIHYDRATE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]2Current NDC, 2 package rows20250110_4965fab0-828d-4f1d-8d43-a636e0a8c1ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2596185Emetrol Chewables 230 MG Chewable TabletPSN4965fab0-828d-4f1d-8d43-a636e0a8c1ea2
2002800sodium citrate 230 MG Chewable TabletPSN4965fab0-828d-4f1d-8d43-a636e0a8c1ea2
2596185sodium citrate 230 MG Chewable Tablet [Emetrol Chewables]SBD4965fab0-828d-4f1d-8d43-a636e0a8c1ea2
2002800sodium citrate 230 MG Chewable TabletSCD4965fab0-828d-4f1d-8d43-a636e0a8c1ea2
2596185Emetrol Chewables 230 MG Chewable TabletSY4965fab0-828d-4f1d-8d43-a636e0a8c1ea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65197-420-60651970420601 BOTTLE in 1 BOX (65197-420-60) / 60 TABLET, CHEWABLE in 1 BOTTLE1 bottle2023-07-01NoNoHistorical