Home NDC 83980-018 ondansetron hydrochloride
Product NDC 83980-018
11-digit product format 839800018
Labeler code 83980
Product ID 83980-018_57713a3e-638c-494d-965e-2399c69dd00f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ondansetron hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ipca Laboratories Limited
Application ANDA203761
Marketing category ANDA
Marketing start 2026-08-14
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 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203761-001 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 A203761-002 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23
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 3 · 86 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 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2014-01-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2014-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2014-01-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2014-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2014-01-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2014-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203761-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2014-01-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203761-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL AB 2014-01-23 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 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 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83980-018-10 83980001810 1000 TABLET, FILM COATED in 1 BOTTLE (83980-018-10) 2026-08-14 No No Current 83980-018-13 83980001813 30 TABLET, FILM COATED in 1 BOTTLE (83980-018-13) 2026-08-14 No No Current 83980-018-97 83980001897 10 TABLET, FILM COATED in 1 BOTTLE (83980-018-97) 2026-08-14 No No Current