Home NDC 0143-9890 Ondansetron
Product NDC 0143-9890
11-digit product format 001439890
Labeler code 0143
Product ID 0143-9890_7dd1fe92-e406-4dde-a0e7-abfc496ccfc3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ondansetron
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler West-Ward Pharmaceuticals Corp
Application ANDA076781
Marketing category ANDA
Marketing start 2006-12-26
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 A076781-001 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2006-12-26
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 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2006-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2006-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION 2006-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076781-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 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 0143-9890-01 Ondansetron 20 mL in 1 VIAL, MULTI-DOSE INJECTION 20 15 0143-9890-10 Ondansetron 10 in 1 CARTON INJECTION 10 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9890 ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICALS CORP] 15 Current NDC, Legacy NDC, 2 package rows 20181215_bb4bc810-db26-471b-9ce7-6e2fb3018af0.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0143-9890-01 00143989001 20 mL in 1 VIAL, MULTI-DOSE (0143-9890-01) 20 ml 2006-12-26 0000-00-00 No No Current 0143-9890-10 00143989010 10 VIAL, MULTI-DOSE in 1 CARTON (0143-9890-10) / 20 mL in 1 VIAL, MULTI-DOSE (0143-9890-01) 2006-12-26 0000-00-00 No No Current