FDA.reportPublic FDA data

Ondansetron

Product NDC
63187-379
11-digit product format
631870379
Labeler code
63187
Product ID
63187-379_0259eb8a-602d-42c0-a4ea-ad936de76410
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
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui104894

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
63187-379-03Ondansetron3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING37
63187-379-05Ondansetron5 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING57
63187-379-06Ondansetron6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING67
63187-379-07Ondansetron7 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING77
63187-379-10Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING107
63187-379-12Ondansetron12 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING127
63187-379-15Ondansetron15 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING157
63187-379-20Ondansetron20 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING207
63187-379-30Ondansetron30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-379-03EA - Each63187-379d11b85b6-9551-4181-be12-bca2969ce18d12017-11-06
63187-379-05EA - Each63187-379781cfe33-daa8-4cef-926f-2d5812f8ddce12018-02-20
63187-379-06EA - Each63187-37950653fcc-db93-479e-9a95-5a731cd8c95a12023-08-08
63187-379-10EA - Each63187-37919d49744-9dbd-4129-aa25-1a10e34ea2ba12016-12-07
63187-379-12EA - Each63187-379fcae795c-77bb-452a-b9f9-cde90f41acf012018-11-06
63187-379-15EA - Each63187-379c301e181-bd80-4363-8702-7067b6aaebe912017-06-15
63187-379-20EA - Each63187-3798f6d028b-c1ed-4e53-a209-281fd405d0d212017-06-15
63187-379-30EA - Each63187-379c1d648df-9426-47e0-b9d4-c386ae57edd912017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-379ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]7Current NDC, Legacy NDC, 9 package rows20230401_bd09b19b-3b7b-474a-9c88-98b813d2c53b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSNbd09b19b-3b7b-474a-9c88-98b813d2c53b7
104894ondansetron 4 MG Disintegrating Oral TabletSCDbd09b19b-3b7b-474a-9c88-98b813d2c53b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-379-03631870379033 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-379-03) 2017-09-010000-00-00NoNoCurrent
63187-379-05631870379055 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-379-05) 2017-10-020000-00-00NoNoCurrent
63187-379-06631870379066 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-379-06) 2023-03-30NoNoHistorical
63187-379-07631870379077 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-379-07) 2023-03-30NoNoHistorical
63187-379-106318703791010 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-379-10) 2016-09-010000-00-00NoNoCurrent
63187-379-126318703791212 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-379-12) 2018-09-040000-00-00NoNoCurrent
63187-379-156318703791515 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-379-15) 2016-09-010000-00-00NoNoCurrent
63187-379-206318703792020 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-379-20) 2016-09-010000-00-00NoNoCurrent
63187-379-306318703793030 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-379-30) 2016-09-010000-00-00NoNoCurrent