FDA.reportPublic FDA data

Ondansetron HCL

Product NDC
80425-0072
11-digit product format
804250072
Labeler code
80425
Product ID
80425-0072_2a9914d0-6554-747c-e063-6294a90a946c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
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 HCL
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
80425-0072-1Ondansetron HCL20 in 1 BOTTLETABLET, FILM COATED209
80425-0072-2Ondansetron HCL30 in 1 BOTTLETABLET, FILM COATED309
80425-0072-3Ondansetron HCL60 in 1 BOTTLETABLET, FILM COATED609
80425-0072-4Ondansetron HCL15 in 1 BOTTLETABLET, FILM COATED159
80425-0072-5Ondansetron HCL10 in 1 BOTTLETABLET, FILM COATED109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0072-1EA - Each80425-0072f4f9f643-eb37-4145-83cb-feb17bc5b76a12023-04-07
80425-0072-2EA - Each80425-0072963d3daf-a33f-463a-a86a-ac0f4878cdf912023-04-07
80425-0072-3EA - Each80425-0072f09d67c1-00d4-47c5-8212-9f8984d0d4a712023-04-07
80425-0072-4EA - Each80425-007203a60e58-449c-4086-bf8a-5aafe67c9dca12023-04-07
80425-0072-5EA - Each80425-0072778a40a8-6800-43d1-b8c7-9e52e8b8a7fb12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0072ONDANSETRON HCL TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 5 package rows20250101_af830edc-ce9e-b038-e053-2a95a90ae974.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSNaf830edc-ce9e-b038-e053-2a95a90ae9749
198052ondansetron 4 MG Oral TabletSCDaf830edc-ce9e-b038-e053-2a95a90ae9749
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYaf830edc-ce9e-b038-e053-2a95a90ae9749

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0072-18042500720120 TABLET, FILM COATED in 1 BOTTLE (80425-0072-1) 2007-07-310000-00-00NoNoCurrent
80425-0072-28042500720230 TABLET, FILM COATED in 1 BOTTLE (80425-0072-2) 2007-07-310000-00-00NoNoCurrent
80425-0072-38042500720360 TABLET, FILM COATED in 1 BOTTLE (80425-0072-3) 2007-07-310000-00-00NoNoCurrent
80425-0072-48042500720415 TABLET, FILM COATED in 1 BOTTLE (80425-0072-4) 2007-07-310000-00-00NoNoCurrent
80425-0072-58042500720510 TABLET, FILM COATED in 1 BOTTLE (80425-0072-5) 2007-07-310000-00-00NoNoCurrent