Home NDC 60687-252 Ondansetron
Product NDC 60687-252
11-digit product format 606870252
Labeler code 60687
Product ID 60687-252_43dfaa03-af7d-df4e-e063-6394a90a9f1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ondansetron
Dosage form SOLUTION
Route ORAL
Labeler American Health Packaging
Application ANDA091483
Marketing category ANDA
Marketing start 2019-02-05
Marketing end 2027-01-31
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 2027-12-31
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 A091483-001 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091483-001 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 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 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 2027-12-31 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 60687-252-40 Ondansetron 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 10 60687-252-46 Ondansetron 10 in 1 TRAY SOLUTION 10 10 60687-252-86 Ondansetron 3 in 1 CASE SOLUTION 3 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-252 ONDANSETRON SOLUTION [AMERICAN HEALTH PACKAGING] 9 Current NDC, Legacy NDC, 3 package rows 20250309_92b96072-e8f2-4fd6-aaa0-b73fed214319.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 60687-252-40 60687025240 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 60687-252-46 60687025246 10 in 1 TRAY Historical 60687-252-86 60687025286 3 TRAY in 1 CASE (60687-252-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-252-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-252-40) 3 tray 2019-02-05 2027-01-31 No No Current