FDA.reportPublic FDA data

Ondansetron

Product NDC
70518-3512
11-digit product format
705183512
Labeler code
70518
Product ID
70518-3512_518ead3d-3105-ffd2-e063-6394a90a8647
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078152
Marketing category
ANDA
Marketing start
2022-09-07
Substance
ONDANSETRON
Active strength
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui104894

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3512-0Ondansetron30 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING3013
70518-3512-1Ondansetron6 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING613
70518-3512-2Ondansetron10 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING1013
70518-3512-3Ondansetron20 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING2013
70518-3512-4Ondansetron12 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING1213
70518-3512-5Ondansetron9 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING913
70518-3512-6Ondansetron21 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING2113
70518-3512-7Ondansetron15 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING1513
70518-3512-8Ondansetron3 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING313

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3512-0EA - Each70518-3512c09bb726-6922-454a-85e3-77953f31aaa812026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3512ONDANSETRON TABLET, ORALLY DISINTEGRATING [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 9 package rows20250313_c0d827d0-333f-4187-ac75-9dc7d34b6169.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSNc0d827d0-333f-4187-ac75-9dc7d34b616913
104894ondansetron 4 MG Disintegrating Oral TabletSCDc0d827d0-333f-4187-ac75-9dc7d34b616913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3512-07051835120030 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-0) 2022-09-070000-00-00NoNoCurrent
70518-3512-1705183512016 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-1) 2022-09-290000-00-00NoNoCurrent
70518-3512-27051835120210 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-2) 2023-10-20NoNoCurrent
70518-3512-37051835120320 in 1 BOX, UNIT-DOSEHistorical
70518-3512-47051835120412 in 1 BOX, UNIT-DOSEHistorical
70518-3512-5705183512059 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-5) 2023-12-23NoNoCurrent
70518-3512-67051835120621 in 1 BOX, UNIT-DOSEHistorical
70518-3512-77051835120715 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-7) 2025-03-06NoNoCurrent
70518-3512-8705183512083 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-8) 2025-07-24NoNoCurrent