VIGADRONE

Manufacturer
Aucta Pharmaceuticals, Inc.
Effective date
2022-11-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:47:44

Label at a glance#

ProductVIGADRONE
Active ingredientVIGABATRIN
Label structure2 sections

Label contents#

Full prescribing information#

HOW SUPPLIED SECTION

VIGADRONE® for oral solution is available as 500 mg packets containing a white to off-white granular powder. They are supplied in cartons of 50 packets (NDC 73289-0002-1).

The oral syringes are provided separately by the pharmacy.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal-display-panelprincipal-display-panel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73289-000273289-0002-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
VIGABATRINGR120KRT6KACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210196-001VIGADRONEVIGABATRIN500MG/PACKETFOR SOLUTION / ORALAA2018-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210196-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-2184e616aacf4f…
2026-08-18 06:07:402026-07A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-213f01610625f2…
2019-09-15 20:21 UTC2019-09A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210196-001VIGADRONE500MG/PACKETFOR SOLUTION / ORALAA2018-06-21f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210196-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A210196-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210196-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210196-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210196-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210196-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210196-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210196-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210196-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210196-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210196-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210196-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210196-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210196-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210196-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210196-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210196-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210196-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210196-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210196-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210196-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210196-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210196-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A210196-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210196-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210196-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210196-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A210196-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210196-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210196-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210196-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210196-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210196-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210196-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210196-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210196-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210196-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210196-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210196-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210196-001AA1f41ea6bd6efb…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f45b0470-8323-0154-e053-2995a90aa2d0dd044b83-e2c8-66e8-e053-2a95a90aa3fd2023-02-10Exact identifier
spl set id: dd044b83-e2c8-66e8-e053-2a95a90aa3fd

Reported adverse events (FAERS/openFDA)#

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