Home NDC 83270-160 ondansetron hydrochloride
Product NDC 83270-160
11-digit product format 832700160
Labeler code 83270
Product ID 83270-160_438c3d28-8bee-50f0-e063-6394a90a18e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ondansetron hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Onesource Specialty Pharma Limited
Application ANDA078244
Marketing category ANDA
Marketing start 2023-09-30
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 2026-12-31
Current FDA listing Yes 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 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23
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 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078244-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION 2008-04-23 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base ondansetron hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ONDANSETRON HYDROCHLORIDE 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NMH84OZK2B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1740467 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83270-160-03 ondansetron hydrochloride 25 in 1 CARTON INJECTION 25 1 83270-160-03 ondansetron hydrochloride 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83270-160-03 83270016003 25 VIAL, SINGLE-DOSE in 1 CARTON (83270-160-03) / 2 mL in 1 VIAL, SINGLE-DOSE 2023-09-30 No No Current