Home NDC 55154-8329-5 Ondansetron
Product NDC 55154-8329
Requested package NDC 55154-8329-5
11-digit product format 551548329
Labeler code 55154
Product ID 55154-8329_7a7fb1ab-8da0-43a2-9054-d0d479e7e070
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ondansetron Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Cardinal Health
Application ANDA202600
Marketing category ANDA
Marketing start 2012-12-21
Marketing end 0000-00-00
Substance ONDANSETRON HYDROCHLORIDE
Active strength 2 mg/mL
Pharmacologic classes Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202600-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# 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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55154-8329-5 55154832905 5 VIAL, SINGLE-DOSE in 1 CARTON (55154-8329-5) > 2 mL in 1 VIAL, SINGLE-DOSE 2012-12-21 0000-00-00 No No Current