FDA.reportPublic FDA data

Ondansetron

Product NDC
68001-246
11-digit product format
680010246
Labeler code
68001
Product ID
68001-246_4c462efc-fa5d-642d-e063-6294a90a5b72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078152
Marketing category
ANDA
Marketing start
2014-03-13
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

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
68001-246-04Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3015
68001-246-16Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1015
68001-246-17Ondansetron30 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-246-04EA - Each68001-2465b479d8b-45c5-4fdb-abf7-0d403d663a5812018-05-09
68001-246-16EA - Each68001-24601dbaef5-a363-4bf6-a042-f5a1f40476ff12017-04-05
68001-246-17EA - Each68001-2465b1a7ee6-314d-4638-a3b5-68ee38dabdfe12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]5
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-246ONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]13Current NDC, Legacy NDC, 3 package rows20220209_ed1132ec-c2cd-4646-b69d-26663bb937a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSNed1132ec-c2cd-4646-b69d-26663bb937a415
312087ondansetron 8 MG Disintegrating Oral TabletPSNed1132ec-c2cd-4646-b69d-26663bb937a415
104894ondansetron 4 MG Disintegrating Oral TabletSCDed1132ec-c2cd-4646-b69d-26663bb937a415
312087ondansetron 8 MG Disintegrating Oral TabletSCDed1132ec-c2cd-4646-b69d-26663bb937a415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-246-046800102460430 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68001-246-04) 2018-02-130000-00-00NoNoCurrent
68001-246-166800102461610 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68001-246-16) 2014-03-130000-00-00NoNoCurrent
68001-246-176800102461730 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68001-246-17) 2014-03-130000-00-00NoNoCurrent