FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
70518-4145
11-digit product format
705184145
Labeler code
70518
Product ID
70518-4145_3fb50021-67ad-645c-e063-6394a90a91b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078539
Marketing category
ANDA
Marketing start
2024-07-18
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
70518-4145-0Ondansetron Hydrochloride16 in 1 BLISTER PACKTABLET, FILM COATED164
70518-4145-1Ondansetron Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED304
70518-4145-2Ondansetron Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED304
70518-4145-3Ondansetron Hydrochloride12 in 1 BOTTLE, PLASTICTABLET, FILM COATED124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4145ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]3Current NDC, 4 package rows20250406_960e2104-18c3-4cfa-abf6-f1b30c452918.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN960e2104-18c3-4cfa-abf6-f1b30c4529184
198052ondansetron 4 MG Oral TabletSCD960e2104-18c3-4cfa-abf6-f1b30c4529184
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY960e2104-18c3-4cfa-abf6-f1b30c4529184

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4145-07051841450016 TABLET, FILM COATED in 1 BLISTER PACK (70518-4145-0) 2024-07-18NoNoCurrent
70518-4145-17051841450130 TABLET, FILM COATED in 1 BLISTER PACK (70518-4145-1) 2024-07-18NoNoCurrent
70518-4145-27051841450230 TABLET, FILM COATED in 1 BLISTER PACK (70518-4145-2) 2024-12-20NoNoCurrent
70518-4145-37051841450312 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4145-3) 2025-04-02NoNoCurrent