Home NDC 83008-074 Ondansetron Hydrochloride
Product NDC 83008-074
11-digit product format 830080074
Labeler code 83008
Product ID 83008-074_f2685012-ffce-483e-b8ad-1846d9d2d6da
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ondansetron Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Quality Care Products, LLC
Application ANDA078539
Marketing category ANDA
Marketing start 2024-07-25
Marketing end 2028-01-31
Substance ONDANSETRON HYDROCHLORIDE
Active strength 4 mg/1
Pharmacologic classes Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag No
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Ondansetron Hydrochloride 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 83008-074-20 Ondansetron Hydrochloride 20 in 1 BOTTLE TABLET, FILM COATED 20 4 83008-074-30 Ondansetron Hydrochloride 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 83008-074 ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC] 4 Current NDC, 2 package rows 20241222_2e0b1b09-9e68-4728-82d5-1f86510a0f2a.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 · 65 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ondansetron ONDANSETRON PharmPak, Inc. 8e289184-6046-4b55-97d2-cb276d5782d5 2022-10-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078539 application number: ANDA078539 Ondansetron Hydrochloride ONDANSETRON HYDROCHLORIDE Pharmpak, Inc. e41b9469-e844-47d9-933a-4c9f4453ecc7 2022-10-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078539 application number: ANDA078539 Ondansetron Hydrochloride ONDANSETRON HYDROCHLORIDE Proficient Rx LP 69ed01b7-a94e-4946-a044-a9f8c37616ec 2022-05-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078539 application number: ANDA078539 Ondansetron Hydrochloride ONDANSETRON HYDROCHLORIDE Proficient Rx LP 381b44e7-a5a1-42ad-bcea-1ab4c82ff5d4 2022-04-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078539 application number: ANDA078539 Ondansetron Hydrochloride ONDANSETRON HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 08db5ce7-4dcf-4581-a0bf-f405cc22b48d 2018-08-27 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078539 application number: ANDA078539
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 83008-074-20 83008007420 20 TABLET, FILM COATED in 1 BOTTLE (83008-074-20) 2024-07-25 2028-01-31 No No Historical 83008-074-30 83008007430 30 TABLET, FILM COATED in 1 BOTTLE (83008-074-30) 2024-07-25 2028-01-31 No No Historical