FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
55700-627
11-digit product format
557000627
Labeler code
55700
Product ID
55700-627_4d8753f4-19f6-44bb-b3c2-8e5c7b98da81
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
2018-05-18
Marketing end
2028-01-31
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
8 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 HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui312086

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
55700-627-10Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED106
55700-627-12Ondansetron Hydrochloride12 in 1 BOTTLETABLET, FILM COATED126
55700-627-20Ondansetron Hydrochloride20 in 1 BOTTLETABLET, FILM COATED206
55700-627-30Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-627-10EA - Each55700-62722363f87-d5cc-4587-9ee8-0fd6c654f72f12018-06-11
55700-627-12EA - Each55700-627d96b0381-8ab2-4d2c-8b7b-1a6a37093c5d12018-06-11
55700-627-20EA - Each55700-627cc1d3a02-90b7-4afb-850b-4a36d49f6a3812018-06-11
55700-627-30EA - Each55700-6273005a319-8e2f-4623-bf6b-7e0c3d2c86af12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-627ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [QUALITY CARE PRODUCTS LLC]6Current NDC, Legacy NDC, 4 package rows20241220_54e8981e-6880-4d4f-bc46-600c2af59698.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSN54e8981e-6880-4d4f-bc46-600c2af596986
312086ondansetron 8 MG Oral TabletSCD54e8981e-6880-4d4f-bc46-600c2af596986
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY54e8981e-6880-4d4f-bc46-600c2af596986

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-627-105570006271010 TABLET, FILM COATED in 1 BOTTLE (55700-627-10) 2018-05-182027-06-30NoNoCurrent
55700-627-125570006271212 TABLET, FILM COATED in 1 BOTTLE (55700-627-12) 2018-05-180000-00-00NoNoCurrent
55700-627-205570006272020 TABLET, FILM COATED in 1 BOTTLE (55700-627-20) 2018-05-182027-06-30NoNoCurrent
55700-627-305570006273030 TABLET, FILM COATED in 1 BOTTLE (55700-627-30) 2018-05-182028-01-31NoNoCurrent