Emetrol Chewables

Product NDC
65197-204
11-digit product format
651970204
Labeler code
65197
Product ID
65197-204_44067ecf-72a5-98ca-e063-6394a90af106
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
2022-03-15
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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-204-42Emetrol Chewables42 in 1 BOTTLETABLET, CHEWABLE427
65197-204-42Emetrol Chewables1 in 1 BOXTABLET, CHEWABLE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65197-204-42EA - Each65197-204d125b18f-2611-4add-9737-d18f1d13838b12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-204EMETROL CHEWABLES (SODIUM CITRATE DIHYDRATE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]6Current NDC, Legacy NDC, 2 package rows20250110_9880a18a-cf84-47cd-99b5-d692065a25bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2596185Emetrol Chewables 230 MG Chewable TabletPSN9880a18a-cf84-47cd-99b5-d692065a25bf7
2002800sodium citrate 230 MG Chewable TabletPSN9880a18a-cf84-47cd-99b5-d692065a25bf7
2596185sodium citrate 230 MG Chewable Tablet [Emetrol Chewables]SBD9880a18a-cf84-47cd-99b5-d692065a25bf7
2002800sodium citrate 230 MG Chewable TabletSCD9880a18a-cf84-47cd-99b5-d692065a25bf7
2596185Emetrol Chewables 230 MG Chewable TabletSY9880a18a-cf84-47cd-99b5-d692065a25bf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65197-204-42651970204421 BOTTLE in 1 BOX (65197-204-42) / 42 TABLET, CHEWABLE in 1 BOTTLE1 bottle2022-03-150000-00-00NoNoCurrent