FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
60760-636
11-digit product format
607600636
Labeler code
60760
Product ID
60760-636_4bd587b0-de3c-c794-e063-6294a90a4ecb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA078539
Marketing category
ANDA
Marketing start
2007-07-31
Substance
ONDANSETRON HYDROCHLORIDE
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 Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052

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
60760-636-10Ondansetron Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1011
60760-636-16Ondansetron Hydrochloride16 in 1 BOTTLE, PLASTICTABLET, FILM COATED1611
60760-636-20Ondansetron Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2011
60760-636-30Ondansetron Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-636-10EA - Each60760-636f43cb7a5-95f1-4aef-817b-fae7ad7140d112017-10-13
60760-636-16EA - Each60760-6365ecdf39c-6f90-4f4a-9793-736fa62e813412023-05-05
60760-636-20EA - Each60760-63697ec5c44-36f8-44d1-9330-5eccb388df8912018-05-09
60760-636-30EA - Each60760-63600212088-8010-43d8-becb-33978245705812019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-636ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]10Current NDC, Legacy NDC, 4 package rows20231209_58f16a00-3e66-29de-e053-2991aa0a59a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN58f16a00-3e66-29de-e053-2991aa0a59a011
198052ondansetron 4 MG Oral TabletSCD58f16a00-3e66-29de-e053-2991aa0a59a011
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY58f16a00-3e66-29de-e053-2991aa0a59a011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-636-106076006361010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-636-10) 2007-07-310000-00-00NoNoCurrent
60760-636-166076006361616 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-636-16) 2023-03-03NoNoHistorical
60760-636-206076006362020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-636-20) 2018-03-260000-00-00NoNoCurrent
60760-636-306076006363030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-636-30) 2019-10-150000-00-00NoNoCurrent