Home NDC 50436-0187-4 Ondansetron Hydrochloride
Product NDC 50436-0187
Requested package NDC 50436-0187-4
11-digit product format 504360187
Labeler code 50436
Product ID 50436-0187_1fbdf71c-6410-4a60-98b2-05e857587bad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ondansetron Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Unit Dose Services
Application ANDA078539
Marketing category ANDA
Marketing start 2007-07-31
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record
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 · 15 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 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 129 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 2026-09-14 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078539-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078539-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078539-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-07-31 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 96 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 50436-0187-1 Ondansetron Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 6 50436-0187-4 Ondansetron Hydrochloride 10 in 1 BOTTLE TABLET, FILM COATED 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50436-0187 ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] 6 Legacy NDC, 2 package rows 20210905_0309ecf4-bb8e-439a-9c15-f749f50576bb.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 Marketing end Sample Exclude flag Status 50436-0187-4 50436018704 10 TABLET, FILM COATED in 1 BOTTLE (50436-0187-4) 2016-07-04 0000-00-00 No No Current