FDA.reportPublic FDA data

NDC 73377-325-01 - Ondansetron HCl Dihydrate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
73377-325
Requested NDC
73377-325-01
Package NDCs from labels
73377-325-01, 73377-325-02
Manufacturer
AX Pharmaceutical Corp | NATCO PHARMA LIMITED
Effective date
2025-09-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ondansetron HCl Dihydrate - AX Pharmaceutical Corp | NATCO PHARMA LIMITEDAX Pharmaceutical Corp | NATCO PHARMA LIMITED2025-09-17BULK INGREDIENT - ANIMAL DRUG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73377-325-01Ondansetron HCl Dihydrate100 g in 1 JARPOWDER1002
73377-325-02Ondansetron HCl Dihydrate500 g in 1 JARPOWDER5002

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 7 · 139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRON HYDROCHLORIDEAtlantic Biologics Corp.41d71d26-0d42-b368-e063-6394a90add432025-10-23Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONCardinal Health 107, LLC61758670-91ab-4422-8d9d-e8ca87eecae82025-10-23Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONAmneal Pharmaceuticals LLC38435346-d505-4bdd-bbc6-a7bcba4110332025-09-23Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPHOENIX RX LLC3a79fc2b-9ea3-a808-e063-6394a90ae7942025-09-22Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPHOENIX RX LLC40106070-6a25-5b0e-e063-6394a90a41972025-09-22Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONFosun Pharma USA Inc.e3f22b7e-b6ad-4799-93c7-d30540cada852025-09-19Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.0b675b09-fe40-435c-b91a-c61cdf767fbf2025-09-15Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPreferred Pharmaceuticals Inc.36d64400-2d13-4a1a-a1ca-4741cd3d3f1a2025-09-03Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONNorthStar Rx LLC9d5e7650-95be-4b96-b29c-374f673eb7a12025-09-03Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDERising Pharma Holdings, Inc.90e0e508-75f7-4c8b-bb38-898aa4c531c32025-09-01Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
ONDANSETRONONDANSETRONProPharma Distribution3d5d25eb-8711-ef8c-e063-6394a90a5e032025-08-27Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
ONDANSETRONONDANSETRONApotex Corp.2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a2025-08-26Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.426ba54f-199a-41d1-8c27-f827bea568542025-08-15Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRON HYDROCHLORIDENorthStar Rx LLCac3dfb81-a4c7-4147-9374-c234153b7c512025-08-11Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONGland Pharma Limited35716914-ac73-43c0-9aa0-09c99211d9412025-07-31Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONGland Pharma Limited3efa5604-96c3-42a0-8e99-b3de4a66aa922025-07-31Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPHOENIX RX LLC3a76bae2-04c2-ee2d-e063-6394a90ad4c82025-07-21Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEAurobindo Pharma Limited57578387-1918-4e56-a564-f14fb22340bf2025-07-19Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRON HYDROCHLORIDEAurobindo Pharma Limitedcf10d256-dd89-4a91-a3ed-81db505a79c22025-07-08Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
ONDANSETRONONDANSETRON HYDROCHLORIDEDr. Reddy's Laboratories Limited162f2088-9fb1-47e7-b88c-45104be7e7bb2025-06-30Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.