Home NDC 51655-415-87 Ondansetron Hydrochloride
Product NDC 51655-415
Requested package NDC 51655-415-87
11-digit product format 516550415
Labeler code 51655
Product ID 51655-415_4b42c5c3-2626-a1d3-e063-6294a90ab9d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ondansetron Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Northwind Health Company, LLC
Application ANDA078539
Marketing category ANDA
Marketing start 2017-12-07
Substance ONDANSETRON HYDROCHLORIDE
Active strength 4 mg/1
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 8dfbde2a14a4…c9ff85d89658…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078539-001 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 A078539-002 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 A078539-003 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 4 · 132 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 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 98 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 Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ONDANSETRON HYDROCHLORIDE 4 mg/1
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 198052 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# NDC, Effective, Related label table NDC Effective Related label 51655-415-04 2023-03-27 These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991 51655-415-43 2023-03-27 These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991 51655-415-53 2023-03-27 These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991 51655-415-54 2023-03-27 These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991 51655-415-55 2023-03-27 These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991 51655-415-87 2023-03-27 These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991 51655-415-04 2021-01-29 These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991 51655-415-43 2021-01-29 These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991 51655-415-53 2021-01-29 These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991 51655-415-54 2021-01-29 These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991 51655-415-55 2021-01-29 These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991 51655-415-87 2021-01-29 These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51655-415-04 Ondansetron Hydrochloride 4 in 1 BOTTLE TABLET, FILM COATED 4 4 51655-415-43 Ondansetron Hydrochloride 3 in 1 BOTTLE TABLET, FILM COATED 3 4 51655-415-53 Ondansetron Hydrochloride 10 in 1 BOTTLE TABLET, FILM COATED 10 4 51655-415-54 Ondansetron Hydrochloride 15 in 1 BOTTLE TABLET, FILM COATED 15 4 51655-415-55 Ondansetron Hydrochloride 5 in 1 BOTTLE TABLET, FILM COATED 5 4 51655-415-87 Ondansetron Hydrochloride 6 in 1 BOTTLE TABLET, FILM COATED 6 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51655-415 ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 6 package rows 20230328_852a3251-bf28-5557-e053-2991aa0a4fbd.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 4 of 4 · 63 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 51655-415-87 51655041587 6 TABLET, FILM COATED in 1 BOTTLE (51655-415-87) 2018-10-24 No No Current