Home NDC 62135-351 ONDANSETRON
Product NDC 62135-351
11-digit product format 621350351
Labeler code 62135
Product ID 62135-351_06fce9d8-ee18-4486-e063-6394a90aeeb4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ONDANSETRON
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA077303
Marketing category ANDA
Marketing start 2007-06-25
Substance ONDANSETRON HYDROCHLORIDE
Active strength 8 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 A077303-001 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 A077303-002 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 A077303-004 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 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 A077303-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077303-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077303-004 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 2007-06-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077303-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077303-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077303-004 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 2007-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077303-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077303-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077303-004 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 2007-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077303-001 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 A077303-002 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 A077303-004 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 2007-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077303-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077303-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077303-004 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 2007-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077303-001 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 A077303-002 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 A077303-004 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 2007-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077303-001 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 A077303-002 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 A077303-004 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 2007-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077303-001 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 A077303-002 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 A077303-004 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 2007-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077303-001 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 A077303-002 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 A077303-004 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 2007-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077303-001 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 A077303-002 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 A077303-004 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 2007-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077303-001 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 A077303-002 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 A077303-004 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 2007-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077303-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077303-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2007-06-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077303-004 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 2007-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077303-001 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 A077303-002 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 A077303-004 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL RS 2007-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077303-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2007-06-25 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 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 8 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198052 Internal RxNorm lookup 312086 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 62135-351-05 ONDANSETRON 500 in 1 BOTTLE TABLET 500 3 62135-351-30 ONDANSETRON 30 in 1 BOTTLE TABLET 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-351 ONDANSETRON TABLET [CHARTWELL RX, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20231006_88b7432b-f5a7-40f3-9b0c-e7b125f5103c.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 · 1 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 62135-351-05 62135035105 500 TABLET in 1 BOTTLE (62135-351-05) 500 tablet 2022-04-20 0000-00-00 No No Current 62135-351-30 62135035130 30 TABLET in 1 BOTTLE (62135-351-30) 30 tablet 2022-04-20 0000-00-00 No No Current