Home NDC 76045-103 ONDANSETRON
Product NDC 76045-103
11-digit product format 760450103
Labeler code 76045
Product ID 76045-103_b71a45e3-2b90-4199-b88b-fef27cb394fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ONDANSETRON HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA202253
Marketing category ANDA
Marketing start 2015-12-10
Substance ONDANSETRON HYDROCHLORIDE
Active strength 4 mg/2mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202253-001 AP
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 · 43 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 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202253-001 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2013-07-19 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ONDANSETRON HYDROCHLORIDE 4 mg/2mL
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 1314133 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 76045-103-00 ONDANSETRON 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 17 76045-103-00 ONDANSETRON 2 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 2 17 76045-103-20 ONDANSETRON 24 in 1 CARTON INJECTION, SOLUTION 24 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76045-103 ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 17 Current NDC, Legacy NDC, 3 package rows 20230824_d89017aa-b8c3-4fd2-8e68-44e2cfd6f290.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 76045-103-00 76045010300 1 in 1 BLISTER PACK Historical 76045-103-20 76045010320 24 BLISTER PACK in 1 CARTON (76045-103-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-103-00) / 2 mL in 1 SYRINGE, GLASS 24 blister pack 2015-12-10 0000-00-00 No No Current