Home NDC 0054-0064 Ondansetron Hydrochloride
Product NDC 0054-0064
11-digit product format 000540064
Labeler code 0054
Product ID 0054-0064_64864cbd-055c-436b-80cc-a65e6ac6b02d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ondansetron Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA076960
Marketing category ANDA
Marketing start 2006-12-26
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 1 .
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 A076960-001 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076960-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA RS 2006-12-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076960-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION / ORAL AA 2006-12-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ondansetron Hydrochloride
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 0054-0064-47 Ondansetron Hydrochloride 1 in 1 CARTON SOLUTION 1 15 0054-0064-47 Ondansetron Hydrochloride 50 mL in 1 BOTTLE, GLASS SOLUTION 50 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ONDANSETRON HYDROCHLORIDE ACTIVE INGREDIENT NMH84OZK2B ONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 ONDANSETRON ACTIVE MOIETY 4AF302ESOS ONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 SACCHARIN SODIUM ANHYDROUS INACTIVE INGREDIENT I4807BK602 ONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 WATER INACTIVE INGREDIENT 059QF0KO0R ONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 Ondansetron Hydrochloride ACTIVE INGREDIENT NMH84OZK2B ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.] 1 Ondansetron ACTIVE MOIETY 4AF302ESOS ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.] 1 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.] 1 saccharin sodium anhydrous INACTIVE INGREDIENT I4807BK602 ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0064 ONDANSETRON HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 14 Current NDC, Legacy NDC, 2 package rows 20211125_1a0c4dc6-643e-4ee7-92a9-edb98049a5ba.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 · 2 matching rows.
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 0054-0064-47 00054006447 1 BOTTLE, GLASS in 1 CARTON (0054-0064-47) / 50 mL in 1 BOTTLE, GLASS 2006-12-26 0000-00-00 No No Current