Ondansetron

Product NDC
43063-592
11-digit product format
430630592
Labeler code
43063
Product ID
43063-592_a8d9e148-9012-6ed1-e053-2995a90ac2a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078050
Marketing category
ANDA
Marketing start
2007-08-13
Marketing end
0000-00-00
Substance
ONDANSETRON
Active strength
8 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43063-592DDiscontinued by firm2026-10-15
excluded packagepackage43063-59243063-592-04DDiscontinued by firm2026-10-15
excluded packagepackage43063-59243063-592-10DDiscontinued by firm2026-10-15

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-592-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-592-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-592-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-592-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-592-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-592-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-592-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-592-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-592-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-592-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-592-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-592-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-592-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-592-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43063-592-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43063-592-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43063-592-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43063-592-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43063-592-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43063-592-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43063-592-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43063-592-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43063-592-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43063-592-04557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078050-001ONDANSETRONONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13
A078050-002ONDANSETRONONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A078050-001AB
A078050-002AB

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 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13c2088c7a36db…
2026-10-15 13:18:302026-09A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13c2088c7a36db…
2026-09-14 22:38:342026-08A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-1384e616aacf4f…
2026-09-14 22:38:342026-08A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-1384e616aacf4f…
2026-08-18 06:07:402026-07A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13caaa826d4ba7…
2026-08-18 06:07:402026-07A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-134b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A078050-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078050-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078050-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078050-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078050-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078050-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078050-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078050-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078050-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078050-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078050-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078050-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078050-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078050-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078050-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078050-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078050-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078050-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078050-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078050-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078050-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078050-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078050-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A078050-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078050-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A078050-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078050-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078050-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078050-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078050-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078050-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078050-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078050-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078050-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078050-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A078050-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078050-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A078050-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078050-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078050-002AB13a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-592-04EA - Each43063-592206d9aee-e2a2-4f0b-a54f-e178d063c52612018-02-20
43063-592-10EA - Each43063-59280afb45f-e6b6-46ca-8d93-473f3a2c650012015-09-10

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-592-04430630592044 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-592-04) 2017-12-260000-00-00NoNoCurrent
43063-592-104306305921010 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-592-10) 2014-12-040000-00-00NoNoCurrent