Home NDC 0173-0489 ZOFRAN
Product NDC 0173-0489
11-digit product format 001730489
Labeler code 0173
Product ID 0173-0489_611b5ddf-6ba0-4811-b040-29004102f56c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ondansetron hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler GlaxoSmithKline LLC
Application NDA020605
Marketing category NDA
Marketing start 1997-02-05
Marketing end 2019-06-30
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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0173-0489-00 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0173-0489-00 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0173-0489-00 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0173-0489-00 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0173-0489-00 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0173-0489-00 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0173-0489-00 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0173-0489-00 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0173-0489-00 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0173-0489-00 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0173-0489-00 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0173-0489-00 557ba5c1ecfa…9c80585c8c6e…
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 N020605-001 ZOFRAN ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 1997-01-24
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 N020605-001 ZOFRAN EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 1997-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020605-001 ZOFRAN EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 1997-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020605-001 ZOFRAN EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 1997-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL RLD 1997-01-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020605-001 ZOFRAN EQ 4MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1997-01-24 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ONDANSETRON ACTIVE INGREDIENT 4AF302ESOS ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 ONDANSETRON HYDROCHLORIDE ACTIVE INGREDIENT NMH84OZK2B ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 ONDANSETRON ACTIVE MOIETY 4AF302ESOS ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 GELATIN INACTIVE INGREDIENT 2G86QN327L ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 METHYLPARABEN SODIUM INACTIVE INGREDIENT CR6K9C2NHK ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 PROPYLPARABEN SODIUM INACTIVE INGREDIENT 625NNB0G9N ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 SORBITOL INACTIVE INGREDIENT 506T60A25R ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15 WATER INACTIVE INGREDIENT 059QF0KO0R ZOFRAN (ONDANSETRON HYDROCHLORIDE) SOLUTION ZOFRAN ODT (ONDANSETRON HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 15