FDA.reportPublic FDA data

Ondansetron

Product NDC
17856-0672
11-digit product format
178560672
Labeler code
17856
Product ID
17856-0672_41d71d34-d0bc-4d2b-e063-6294a90aa350
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologics Corp.
Application
ANDA078776
Marketing category
ANDA
Marketing start
2007-11-28
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 mg/5mL
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
ONDANSETRON HYDROCHLORIDE4 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui312085

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0672-1Ondansetron60 in 1 CASESOLUTION601
17856-0672-1Ondansetron2.5 mL in 1 SYRINGESOLUTION2.51
17856-0672-2Ondansetron120 in 1 CASESOLUTION1201
17856-0672-2Ondansetron2.5 mL in 1 SYRINGESOLUTION2.51
17856-0672-3Ondansetron120 in 1 CASESOLUTION1201
17856-0672-3Ondansetron2.5 mL in 1 SYRINGESOLUTION2.51
17856-0672-4Ondansetron72 in 1 CASESOLUTION721
17856-0672-4Ondansetron5 mL in 1 CUP, UNIT-DOSESOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0672-1ML - Milliliter17856-0672f5b97fd9-6050-46e6-b0da-693821d3938a12026-03-17
17856-0672-2ML - Milliliter17856-0672787cc894-2cc2-4952-981c-f67609a087e312026-03-17
17856-0672-3ML - Milliliter17856-067253831650-5a50-4e31-9590-1c0ac60dc7ec12026-03-17
17856-0672-4ML - Milliliter17856-067268c3eadb-fcbb-40cc-80d0-0ddc4021b83a12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSN41d71d26-0d42-b368-e063-6394a90add431
312085ondansetron 0.8 MG/ML Oral SolutionSCD41d71d26-0d42-b368-e063-6394a90add431
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSY41d71d26-0d42-b368-e063-6394a90add431
312085ondansetron 4 MG per 5 ML Oral SolutionSY41d71d26-0d42-b368-e063-6394a90add431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-0672-11785606720160 SYRINGE in 1 CASE (17856-0672-1) / 2.5 mL in 1 SYRINGE60 syringe2025-10-23NoNoCurrent
17856-0672-217856067202120 SYRINGE in 1 CASE (17856-0672-2) / 2.5 mL in 1 SYRINGE120 syringe2025-10-23NoNoCurrent
17856-0672-317856067203120 SYRINGE in 1 CASE (17856-0672-3) / 2.5 mL in 1 SYRINGE120 syringe2025-10-23NoNoCurrent
17856-0672-41785606720472 CUP, UNIT-DOSE in 1 CASE (17856-0672-4) / 5 mL in 1 CUP, UNIT-DOSE2025-10-23NoNoCurrent