Home NDC 65162-691 Ondansetron
Product NDC 65162-691
11-digit product format 651620691
Labeler code 65162
Product ID 65162-691_7421d60d-7d82-4ec5-885a-255c507c32a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ondansetron
Dosage form SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA091483
Marketing category ANDA
Marketing start 2010-12-17
Substance ONDANSETRON HYDROCHLORIDE
Active strength 4 mg/5mL
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091483-001 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091483-001 AA
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091483-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2011-01-31 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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/5mL
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 312085 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 65162-691-19 Ondansetron 10 in 1 TRAY SOLUTION 10 26 65162-691-37 Ondansetron 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 26 65162-691-79 Ondansetron 50 mL in 1 BOTTLE SOLUTION 50 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ONDANSETRON HYDROCHLORIDE ACTIVE INGREDIENT NMH84OZK2B ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 ONDANSETRON ACTIVE MOIETY 4AF302ESOS ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 WATER INACTIVE INGREDIENT 059QF0KO0R ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 ONDANSETRON HYDROCHLORIDE ACTIVE INGREDIENT NMH84OZK2B ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 ONDANSETRON HYDROCHLORIDE ACTIVE INGREDIENT NMH84OZK2B ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 ONDANSETRON ACTIVE MOIETY 4AF302ESOS ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 ONDANSETRON ACTIVE MOIETY 4AF302ESOS ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 STRAWBERRY INACTIVE INGREDIENT 4J2TY8Y81V ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 STRAWBERRY INACTIVE INGREDIENT 4J2TY8Y81V ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-691 ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS LLC] 23 Current NDC, Legacy NDC, 3 package rows 20250207_38435346-d505-4bdd-bbc6-a7bcba411033.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 · 4 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 65162-691-19 65162069119 10 CUP, UNIT-DOSE in 1 TRAY (65162-691-19) / 5 mL in 1 CUP, UNIT-DOSE (65162-691-37) 2010-12-17 No No Current 65162-691-37 65162069137 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 65162-691-79 65162069179 50 mL in 1 BOTTLE (65162-691-79) 50 ml 2010-12-17 0000-00-00 No No Current