Ondansetron

Product NDC
70860-776
11-digit product format
708600776
Labeler code
70860
Product ID
70860-776_e24e8318-7890-4329-8cdb-2133cf4c29bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA079224
Marketing category
ANDA
Marketing start
2017-01-01
Marketing end
0000-00-00
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-776-022024-03-04C16284748780-11030e365-68e1-111a-e063-dadaa90a10e204e315ea-f820-4ae2-b237-ea5b8722fa9f
70860-776-022024-01-30C16284748780-11030e365-68e1-111a-e063-dadaa90a10e204e315ea-f820-4ae2-b237-ea5b8722fa9f

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-776-02ML - Milliliter70860-776cb58f9c6-34ca-4b95-b5cf-89a6f15c551312017-03-06
70860-776-41ML - Milliliter70860-776d46ced69-c0d1-48e9-9c87-4d7ccd01a30012019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-776ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]11Legacy NDC20240306_04e315ea-f820-4ae2-b237-ea5b8722fa9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740467ondansetron 4 MG in 2 ML InjectionPSN6a265130-d344-5744-e053-2a91aa0a89553
17404672 ML ondansetron 2 MG/ML InjectionSCD6a265130-d344-5744-e053-2a91aa0a89553
1740467ondansetron 4 MG per 2 ML InjectionSY6a265130-d344-5744-e053-2a91aa0a89553

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70860-776-027086007760225 VIAL, SINGLE-DOSE in 1 CARTON (70860-776-02) > 2 mL in 1 VIAL, SINGLE-DOSE (70860-776-41) 2018-06-300000-00-00NoNoCurrent