Home NDC 51662-1245 ONDANSETRON
Product NDC 51662-1245
11-digit product format 516621245
Labeler code 51662
Product ID 51662-1245_1200224e-aa61-639d-e063-6294a90ac4b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ONDANSETRON
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA077541
Marketing category ANDA
Marketing start 2018-09-23
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 44 .
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 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE 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 A077541-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077541-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2006-12-26 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 1740467 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51662-1245-1 ONDANSETRON 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 7 51662-1245-2 ONDANSETRON 2 mL in 1 VIAL INJECTION 2 7 51662-1245-2 ONDANSETRON 1 in 1 POUCH INJECTION 1 7 51662-1245-3 ONDANSETRON 25 in 1 CASE INJECTION 25 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1245 ONDANSETRON INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 7 Current NDC, Legacy NDC, 4 package rows 20240224_768aa02b-8231-5799-e053-2a91aa0a618d.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ondansetron ONDANSETRON Civica, Inc. 70437694-0341-4f3b-824c-06843403443f 2026-04-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077541 application number: ANDA077541 Ondansetron ONDANSETRON Hikma Pharmaceuticals USA Inc. 97713356-f42b-4a67-95f6-561afa68c0c2 2026-04-16 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077541 application number: ANDA077541 Ondansetron ONDANSETRON Hikma Pharmaceuticals USA Inc. c29ca6df-621d-44b6-98fc-b48666573366 2026-04-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077541 application number: ANDA077541 ONDANSETRON ONDANSETRON HF Acquisition Co LLC, DBA HealthFirst 768aa02b-8231-5799-e053-2a91aa0a618d 2024-02-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077541 application number: ANDA077541 ndc (product): 51662-1245 Ondansetron ONDANSETRON Medical Purchasing Solutions, LLC 70bf93bc-e979-f080-e053-2991aa0a21df 2023-05-16 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077541 application number: ANDA077541
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 51662-1245-1 51662124501 2 mL in 1 VIAL, SINGLE-DOSE (51662-1245-1) 2 ml 2018-09-23 0000-00-00 No No Current 51662-1245-2 51662124502 2 mL in 1 VIAL 2 ml Historical 51662-1245-3 51662124503 25 POUCH in 1 CASE (51662-1245-3) / 1 VIAL in 1 POUCH (51662-1245-2) / 2 mL in 1 VIAL 25 pouch 2018-09-23 No No Current