Home NDC 55150-126 Ondansetron
Product NDC 55150-126
11-digit product format 551500126
Labeler code 55150
Product ID 55150-126_344b6a95-a41f-4ef0-8434-623257a5f9c5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ondansetron Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Eugia US LLC
Application ANDA202599
Marketing category ANDA
Marketing start 2012-12-21
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 A202599-001 ONDANSETRON HYDROCHLORIDE 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 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2012-12-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202599-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2012-12-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ondansetron
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283504 Internal RxNorm lookup 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 55150-126-20 Ondansetron 1 in 1 CARTON INJECTION, SOLUTION 1 11 55150-126-20 Ondansetron 20 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 20 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ONDANSETRON HYDROCHLORIDE ACTIVE INGREDIENT NMH84OZK2B ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] 6 ONDANSETRON ACTIVE MOIETY 4AF302ESOS ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] 6 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] 6 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] 6 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] 6 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] 6 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] 6 WATER INACTIVE INGREDIENT 059QF0KO0R ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-126 ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [EUGIA US LLC] 11 Current NDC, Legacy NDC, 2 package rows 20240120_1cc94c7a-617c-4238-8248-e3fabc9612c7.zip
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 Marketing end Sample Exclude flag Status 55150-126-20 55150012620 1 VIAL, MULTI-DOSE in 1 CARTON (55150-126-20) / 20 mL in 1 VIAL, MULTI-DOSE 2012-12-21 0000-00-00 No No Current