Amantadine Hydrochloride

Product NDC
0591-4930
11-digit product format
005914930
Labeler code
0591
Product ID
0591-4930_4c45e77a-6267-480a-8d4e-4dc8e919329e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA208107
Marketing category
ANDA
Marketing start
2017-01-25
Marketing end
2021-01-31
Substance
AMANTADINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct0591-4930DDiscontinued by firm2026-08-17
excluded packagepackage0591-49300591-4930-01DDiscontinued by firm2026-08-17
excluded packagepackage0591-49300591-4930-05DDiscontinued 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 1 · 50 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0591-4930-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0591-4930-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0591-4930-01DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0591-4930-05DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0591-4930-01DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0591-4930-05DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0591-4930-01DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0591-4930-05DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0591-4930-01DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0591-4930-05DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0591-4930-01DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0591-4930-05DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0591-4930-01DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0591-4930-05DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0591-4930-01DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0591-4930-05DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0591-4930-01DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0591-4930-05DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0591-4930-01DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0591-4930-05DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0591-4930-01DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0591-4930-05DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0591-4930-01DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0591-4930-05DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage0591-4930-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage0591-4930-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip6db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage0591-4930-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage0591-4930-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage0591-4930-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage0591-4930-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage0591-4930-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…

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

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
A208107-001AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-06

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-063f01610625f2…
2019-09-15 20:21 UTC2019-09A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORAL2016-12-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208107-001AMANTADINE HYDROCHLORIDE100MGCAPSULE / ORALAB2016-12-06e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208107-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208107-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208107-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208107-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208107-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208107-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208107-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208107-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208107-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208107-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208107-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208107-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208107-001AB1ea99ee380514…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208107-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208107-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208107-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208107-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-4930-01EA - Each0591-4930c9a3e0e8-d873-4788-a95c-02eef4bccc3112017-03-06
0591-4930-05EA - Each0591-4930c45966d9-3d76-4e93-a4e2-6a153fd4529112017-06-15