Home NDC 67296-2119-3 Ondansetron
Product NDC 67296-2119
Requested package NDC 67296-2119-3
11-digit product format 672962119
Labeler code 67296
Product ID 67296-2119_4698a594-cf21-0365-e063-6294a90a8784
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ondansetron
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Redpharm Drug
Application ANDA077535
Marketing category ANDA
Marketing start 2007-06-25
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 2026-12-31
Current FDA listing Yes 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 A077535-001 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 A077535-002 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 A077535-003 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25
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 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077535-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077535-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077535-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077535-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077535-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077535-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077535-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077535-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077535-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077535-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077535-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077535-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077535-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077535-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077535-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077535-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077535-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077535-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077535-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077535-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077535-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077535-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077535-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077535-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077535-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077535-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2007-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077535-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 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.
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/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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67296-2119-3 Ondansetron 30 in 1 BOTTLE TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-2119 ONDANSETRON TABLET, FILM COATED [REDPHARM DRUG] 1 Current NDC, 1 package rows 20250312_300b1916-a3d8-0220-e063-6394a90a6f55.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 · 3 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 67296-2119-3 67296211903 30 TABLET, FILM COATED in 1 BOTTLE (67296-2119-3) 2007-06-25 No No Current