FDA.reportPublic FDA data

Ondansetron

Product NDC
71205-713
11-digit product format
712050713
Labeler code
71205
Product ID
71205-713_35203011-d93c-4169-a9cb-90b6d20b146b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
Substance
ONDANSETRON
Active strength
8 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
ONDANSETRON8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui312087

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
71205-713-10Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING103
71205-713-10Ondansetron1 in 1 BAGTABLET, ORALLY DISINTEGRATING13
71205-713-20Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING103
71205-713-20Ondansetron2 in 1 BAGTABLET, ORALLY DISINTEGRATING23
71205-713-30Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING303
71205-713-60Ondansetron60 in 1 BOTTLETABLET, ORALLY DISINTEGRATING603
71205-713-90Ondansetron90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-713-10EA - Each71205-713451fc6d3-9f71-466f-b702-ad5fc0190cc612023-03-13
71205-713-20EA - Each71205-7137390aa85-885f-48d6-8b2a-f2c1c8a11d0512023-03-13
71205-713-30EA - Each71205-7133e7defa6-6a78-4f3c-8f50-3de57f718ac512023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-713ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]3Current NDC, Legacy NDC, 7 package rows20230106_47e26779-9465-410c-96b3-091119ae62f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN47e26779-9465-410c-96b3-091119ae62f23
312087ondansetron 8 MG Disintegrating Oral TabletSCD47e26779-9465-410c-96b3-091119ae62f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-713-10712050713101 BLISTER PACK in 1 BAG (71205-713-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2022-11-170000-00-00NoNoCurrent
71205-713-20712050713202 BLISTER PACK in 1 BAG (71205-713-20) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2022-11-170000-00-00NoNoCurrent
71205-713-307120507133030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71205-713-30) 2022-11-210000-00-00NoNoCurrent
71205-713-607120507136060 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71205-713-60) 2022-11-210000-00-00NoNoCurrent
71205-713-907120507139090 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71205-713-90) 2022-11-210000-00-00NoNoCurrent