FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
63187-636
11-digit product format
631870636
Labeler code
63187
Product ID
63187-636_2996955e-2b6c-4702-8c4a-6ab17c9e6e87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
63187-636-01Ondansetron Hydrochloride01 in 1 BOTTLETABLET, FILM COATED017
63187-636-03Ondansetron Hydrochloride3 in 1 BOTTLETABLET, FILM COATED37
63187-636-06Ondansetron Hydrochloride6 in 1 BOTTLETABLET, FILM COATED67
63187-636-10Ondansetron Hydrochloride10 in 1 CARTONTABLET, FILM COATED107
63187-636-10Ondansetron Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED107
63187-636-12Ondansetron Hydrochloride12 in 1 BOTTLETABLET, FILM COATED127
63187-636-15Ondansetron Hydrochloride15 in 1 BOTTLETABLET, FILM COATED157
63187-636-20Ondansetron Hydrochloride20 in 1 BOTTLETABLET, FILM COATED207
63187-636-30Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-636-01EA - Each63187-63601a7afde-e1d2-4176-968b-486a790ee98312018-11-06
63187-636-03EA - Each63187-636439bbfa4-3086-4911-ad08-b8d46292185112017-06-15
63187-636-06EA - Each63187-636a5a792c3-ad64-417e-84ac-72a932639cfe12019-10-07
63187-636-10EA - Each63187-6362e1752be-e282-4c40-a100-88cd983f89e912017-03-06
63187-636-12EA - Each63187-636b8a367ae-9159-476d-a2cf-9ff25b59870e12018-11-06
63187-636-15EA - Each63187-636454c1ed3-e61f-413f-a5c6-489d573740ae12018-08-13
63187-636-20EA - Each63187-636748bd017-99df-436e-8727-7cb2c6c2e63012023-08-08
63187-636-30EA - Each63187-6366600bd42-a08d-4327-820b-cd05743ad64812017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-636ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]7Current NDC, Legacy NDC, 9 package rows20220419_381b44e7-a5a1-42ad-bcea-1ab4c82ff5d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN381b44e7-a5a1-42ad-bcea-1ab4c82ff5d47
198052ondansetron 4 MG Oral TabletSCD381b44e7-a5a1-42ad-bcea-1ab4c82ff5d47
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY381b44e7-a5a1-42ad-bcea-1ab4c82ff5d47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-636-01631870636011 TABLET, FILM COATED in 1 BOTTLE (63187-636-01) 2018-09-040000-00-00NoNoCurrent
63187-636-03631870636033 TABLET, FILM COATED in 1 BOTTLE (63187-636-03) 2017-05-010000-00-00NoNoCurrent
63187-636-06631870636066 TABLET, FILM COATED in 1 BOTTLE (63187-636-06) 2019-08-010000-00-00NoNoCurrent
63187-636-106318706361010 BLISTER PACK in 1 CARTON (63187-636-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2016-05-020000-00-00NoNoCurrent
63187-636-126318706361212 TABLET, FILM COATED in 1 BOTTLE (63187-636-12) 2018-09-040000-00-00NoNoCurrent
63187-636-156318706361515 TABLET, FILM COATED in 1 BOTTLE (63187-636-15) 2016-05-020000-00-00NoNoCurrent
63187-636-206318706362020 TABLET, FILM COATED in 1 BOTTLE (63187-636-20) 2016-05-020000-00-00NoNoCurrent
63187-636-306318706363030 TABLET, FILM COATED in 1 BOTTLE (63187-636-30) 2016-05-020000-00-00NoNoCurrent