Home NDC 65862-208 Ondansetron
Product NDC 65862-208
11-digit product format 658620208
Labeler code 65862
Product ID 65862-208_a839599f-f788-4039-9e34-b443d1c9849b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ondansetron Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA078776
Marketing category ANDA
Marketing start 2007-11-28
Substance ONDANSETRON HYDROCHLORIDE
Active strength 4 mg/5mL
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 A078776-001 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078776-001 AA
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 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078776-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2007-11-28 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 4 mg/5mL
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 312085 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 65862-208-04 Ondansetron 1 in 1 CARTON SOLUTION 1 17 65862-208-04 Ondansetron 50 mL in 1 BOTTLE, PLASTIC SOLUTION 50 17 65862-208-50 Ondansetron 50 mL in 1 BOTTLE SOLUTION 50 17 65862-208-50 Ondansetron 1 in 1 CARTON SOLUTION 1 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-208 ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED] 16 Current NDC, Legacy NDC, 4 package rows 20231213_cf10d256-dd89-4a91-a3ed-81db505a79c2.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 · 4 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 65862-208-04 65862020804 1 BOTTLE, PLASTIC in 1 CARTON (65862-208-04) / 50 mL in 1 BOTTLE, PLASTIC 2007-11-28 0000-00-00 No No Current 65862-208-50 65862020850 1 BOTTLE in 1 CARTON (65862-208-50) / 50 mL in 1 BOTTLE 1 bottle 2007-11-28 0000-00-00 No No Current