FDA.reportPublic FDA data

Ondansetron

Product NDC
43063-857
11-digit product format
430630857
Labeler code
43063
Product ID
43063-857_3ed995a4-00a5-c1d0-e063-6394a90a0298
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
Substance
ONDANSETRON
Active strength
4 mg/1
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
ONDANSETRON4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui104894

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
43063-857-02Ondansetron2 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING233
43063-857-04Ondansetron4 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING433
43063-857-05Ondansetron5 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING533
43063-857-06Ondansetron6 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING633
43063-857-08Ondansetron8 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING833
43063-857-10Ondansetron10 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING1033
43063-857-20Ondansetron20 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING2033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-857-02EA - Each43063-857c3d742da-30ae-4b75-8473-a600cec967e312018-07-03
43063-857-04EA - Each43063-857ec0d4eef-7def-4695-b61c-a9cfe6d9a16e12018-07-03
43063-857-05EA - Each43063-8571e45cdcb-f690-4b2c-9c59-26131a686b7612018-07-03
43063-857-06EA - Each43063-857ea9dd9b2-e744-4887-92f6-374c51adb0be12018-07-03
43063-857-08EA - Each43063-8575f04713e-a702-412f-a62a-7b65a71feddc12019-07-02
43063-857-10EA - Each43063-857427e336d-048b-498d-ac35-2d147e53ff1c12018-08-13
43063-857-20EA - Each43063-857c1f837b5-0b5b-42dd-93b0-df72455807d412018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-857ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]32Current NDC, Legacy NDC, 7 package rows20240704_9558d296-8edd-4aa1-875a-6247f9a8374d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN9558d296-8edd-4aa1-875a-6247f9a8374d33
104894ondansetron 4 MG Disintegrating Oral TabletSCD9558d296-8edd-4aa1-875a-6247f9a8374d33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-857-02430630857022 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-02) 2018-06-040000-00-00NoNoCurrent
43063-857-04430630857044 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-04) 2018-06-120000-00-00NoNoCurrent
43063-857-05430630857055 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-05) 2018-06-120000-00-00NoNoCurrent
43063-857-06430630857066 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-06) 2018-06-040000-00-00NoNoCurrent
43063-857-08430630857088 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-08) 2018-06-070000-00-00NoNoCurrent
43063-857-104306308571010 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-10) 2018-06-180000-00-00NoNoCurrent
43063-857-204306308572020 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-20) 2018-08-210000-00-00NoNoCurrent