Home NDC 51662-1377 ONDANSETRON
Product NDC 51662-1377
11-digit product format 516621377
Labeler code 51662
Product ID 51662-1377_12504be9-9bd0-31db-e063-6394a90abc57
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ONDANSETRON
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA076974
Marketing category ANDA
Marketing start 2020-05-21
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 A076974-001 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076974-001 AP
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 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076974-001 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 A076974-001 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 A076974-001 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 A076974-001 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 A076974-001 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 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076974-001 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 A076974-001 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 A076974-001 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 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076974-001 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 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076974-001 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 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076974-001 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 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076974-001 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 A076974-001 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 A076974-001 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 A076974-001 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 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076974-001 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 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076974-001 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 A076974-001 ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283504 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 51662-1377-1 ONDANSETRON 20 mL in 1 VIAL INJECTION 20 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1377 ONDANSETRON INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 2 Current NDC, Legacy NDC, 1 package rows 20240228_a62e2a6a-6235-7580-e053-2a95a90aa2b0.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 51662-1377-1 51662137701 20 mL in 1 VIAL (51662-1377-1) 20 ml 2020-05-21 0000-00-00 No No Current