FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
55700-631
11-digit product format
557000631
Labeler code
55700
Product ID
55700-631_a02a2f64-0dd6-4871-9b00-95d64bdede3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA078539
Marketing category
ANDA
Marketing start
2018-05-25
Marketing end
2028-01-31
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron Hydrochloride

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
55700-631-06Ondansetron Hydrochloride6 in 1 BOTTLETABLET, FILM COATED67
55700-631-10Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED107
55700-631-20Ondansetron Hydrochloride20 in 1 BOTTLETABLET, FILM COATED207
55700-631-30Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-631-06EA - Each55700-631fe87c64b-20d1-4ab0-9585-9d28a214820d12018-06-11
55700-631-10EA - Each55700-631958e7126-565f-4c39-b9d9-14e05de92a2d12018-06-11
55700-631-20EA - Each55700-631c841348a-05fd-455a-8ea2-ec891d59c7e412018-06-11
55700-631-30EA - Each55700-6312cabfceb-b186-4ae9-b1ab-7a175d11bfa512018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-631ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [QUALITY CARE PRODUCTS LLC]7Current NDC, Legacy NDC, 4 package rows20241220_89091629-d15e-4e95-aed8-8bc983c78302.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN89091629-d15e-4e95-aed8-8bc983c783027
198052ondansetron 4 MG Oral TabletSCD89091629-d15e-4e95-aed8-8bc983c783027
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY89091629-d15e-4e95-aed8-8bc983c783027

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-631-06557000631066 TABLET, FILM COATED in 1 BOTTLE (55700-631-06) 2018-05-250000-00-00NoNoCurrent
55700-631-105570006311010 TABLET, FILM COATED in 1 BOTTLE (55700-631-10) 2018-05-252027-05-31NoNoCurrent
55700-631-205570006312020 TABLET, FILM COATED in 1 BOTTLE (55700-631-20) 2018-05-252027-05-31NoNoCurrent
55700-631-305570006313030 TABLET, FILM COATED in 1 BOTTLE (55700-631-30) 2018-05-252028-01-31NoNoCurrent