FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
62135-555
11-digit product format
621350555
Labeler code
62135
Product ID
62135-555_476a94c7-d201-ccb7-e063-6294a90a8cd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA091342
Marketing category
ANDA
Marketing start
2011-01-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron Hydrochloride
Listing expiration
2027-12-31

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-555-24Ondansetron Hydrochloride10 in 1 TRAYSOLUTION104
62135-555-24Ondansetron Hydrochloride2 in 1 BOXSOLUTION24
62135-555-45Ondansetron Hydrochloride5 mL in 1 PACKAGESOLUTION54
62135-555-58Ondansetron Hydrochloride50 mL in 1 BOTTLESOLUTION504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-555-24ML - Milliliter62135-55573ae74b6-08c8-486b-9fc6-2b3607d4bdd012024-09-09
62135-555-45ML - Milliliter62135-55552e79c04-dec0-48fe-af21-e41b898c11b512024-09-09
62135-555-58ML - Milliliter62135-55546581fb1-0ceb-4bea-b0cc-2e4b81bf3a0a12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-555ONDANSETRON HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC.]3Current NDC, Legacy NDC, 4 package rows20240601_2086bae8-7c3c-4663-93ac-c86407c524c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSN2086bae8-7c3c-4663-93ac-c86407c524c24
312085ondansetron 0.8 MG/ML Oral SolutionSCD2086bae8-7c3c-4663-93ac-c86407c524c24
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSY2086bae8-7c3c-4663-93ac-c86407c524c24
312085ondansetron 4 MG per 5 ML Oral SolutionSY2086bae8-7c3c-4663-93ac-c86407c524c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-555-24621350555242 TRAY in 1 BOX (62135-555-24) / 10 PACKAGE in 1 TRAY / 5 mL in 1 PACKAGE (62135-555-45) 2 tray2024-05-28NoNoHistorical
62135-555-45621350555455 mL in 1 PACKAGE5 mlHistorical
62135-555-586213505555850 mL in 1 BOTTLE (62135-555-58) 50 ml2022-10-040000-00-00NoNoCurrent