Ondansetron

Product NDC
71335-0491
11-digit product format
713350491
Labeler code
71335
Product ID
71335-0491_7f8aba0e-64ed-45ec-bf6d-d8d919136686
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078050
Marketing category
ANDA
Marketing start
2007-08-31
Marketing end
0000-00-00
Substance
ONDANSETRON
Active strength
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0491DDiscontinued by firm2026-08-17
excluded packagepackage71335-049171335-0491-0DDiscontinued by firm2026-08-17
excluded packagepackage71335-049171335-0491-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-049171335-0491-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-049171335-0491-3DDiscontinued by firm2026-08-17
excluded packagepackage71335-049171335-0491-4DDiscontinued by firm2026-08-17
excluded packagepackage71335-049171335-0491-5DDiscontinued by firm2026-08-17
excluded packagepackage71335-049171335-0491-6DDiscontinued by firm2026-08-17
excluded packagepackage71335-049171335-0491-7DDiscontinued by firm2026-08-17
excluded packagepackage71335-049171335-0491-8DDiscontinued by firm2026-08-17
excluded packagepackage71335-049171335-0491-9DDiscontinued by firm2026-08-17

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 3 · 132 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 packagepackage71335-0491-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0491-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0491-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0491-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0491-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0491-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0491-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0491-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0491-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0491-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0491-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0491-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0491-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0491-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0491-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0491-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0491-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0491-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0491-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0491-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0491-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0491-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0491-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0491-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0491-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0491-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0491-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0491-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0491-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0491-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0491-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0491-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0491-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0491-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0491-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0491-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0491-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0491-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0491-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0491-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0491-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0491-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0491-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0491-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0491-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0491-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0491-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0491-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0491-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0491-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0491-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0491-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0491-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0491-5cdf11ea48f46…ba0047e9e063…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2019-12-13 00:20 UTC2019-12A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078050-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078050-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-08-13bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078050-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078050-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078050-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078050-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078050-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078050-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078050-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078050-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078050-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078050-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078050-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078050-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078050-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078050-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078050-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078050-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078050-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078050-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078050-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078050-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078050-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078050-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078050-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078050-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078050-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078050-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078050-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078050-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078050-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078050-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078050-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078050-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078050-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078050-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078050-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078050-002AB14b0b4de00fa7…
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…