FDA.reportPublic FDA data

Ondansetron

Product NDC
16714-200
11-digit product format
167140200
Labeler code
16714
Product ID
16714-200_952aa289-4c91-49b8-aad8-610855b0a6e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA090469
Marketing category
ANDA
Marketing start
2021-04-27
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui104894, 312087

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-200-10Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING107
16714-200-30Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-200-10EA - Each16714-200d36b0ff9-ff38-4551-a639-055293e4994e12022-12-07
16714-200-30EA - Each16714-20018b67969-4bbd-426e-9733-e8088a7ac7bc12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-200ONDANSETRON TABLET, ORALLY DISINTEGRATING [NORTHSTAR RX LLC]6Current NDC, Legacy NDC, 2 package rows20231216_281e4296-1d0e-4602-9912-2685ba1640f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN281e4296-1d0e-4602-9912-2685ba1640f67
312087ondansetron 8 MG Disintegrating Oral TabletPSN281e4296-1d0e-4602-9912-2685ba1640f67
104894ondansetron 4 MG Disintegrating Oral TabletSCD281e4296-1d0e-4602-9912-2685ba1640f67
312087ondansetron 8 MG Disintegrating Oral TabletSCD281e4296-1d0e-4602-9912-2685ba1640f67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-200-101671402001010 in 1 BLISTER PACKHistorical
16714-200-30167140200303 BLISTER PACK in 1 CARTON (16714-200-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (16714-200-10) 3 blister pack2021-04-270000-00-00NoNoCurrent