FDA.reportPublic FDA data

ondansetron

Product NDC
63187-513
11-digit product format
631870513
Labeler code
63187
Product ID
63187-513_48ce80a1-5af3-465e-96d9-ef192cafafe3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077851
Marketing category
ANDA
Marketing start
2007-06-25
Substance
ONDANSETRON HYDROCHLORIDE
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
ONDANSETRON HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui312086

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
63187-513-10ondansetron10 in 1 BOTTLETABLET, FILM COATED103
63187-513-15ondansetron15 in 1 BOTTLETABLET, FILM COATED153
63187-513-20ondansetron20 in 1 BOTTLETABLET, FILM COATED203
63187-513-30ondansetron30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-513-10EA - Each63187-51321ff7ce5-219b-47ce-94ab-5f09e173b00012015-11-12
63187-513-30EA - Each63187-513e8c0b864-d090-4a22-a0cd-2eecaaefca6b12017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-513ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20210114_bde7c22c-0047-4735-8df6-b48e8dfa478a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSNbde7c22c-0047-4735-8df6-b48e8dfa478a3
312086ondansetron 8 MG Oral TabletSCDbde7c22c-0047-4735-8df6-b48e8dfa478a3
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYbde7c22c-0047-4735-8df6-b48e8dfa478a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-513-106318705131010 TABLET, FILM COATED in 1 BOTTLE (63187-513-10) 2018-12-010000-00-00NoNoCurrent
63187-513-156318705131515 TABLET, FILM COATED in 1 BOTTLE (63187-513-15) 2018-12-010000-00-00NoNoCurrent
63187-513-206318705132020 TABLET, FILM COATED in 1 BOTTLE (63187-513-20) 2018-12-010000-00-00NoNoCurrent
63187-513-306318705133030 TABLET, FILM COATED in 1 BOTTLE (63187-513-30) 2018-12-010000-00-00NoNoCurrent