Amantadine Hydrochloride

Product NDC
73152-075
11-digit product format
731520075
Labeler code
73152
Product ID
73152-075_bbb43284-8884-d38e-e053-2995a90a1dcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Athem LLC
Application
ANDA210215
Marketing category
ANDA
Marketing start
2021-02-19
Marketing end
0000-00-00
Substance
AMANTADINE HYDROCHLORIDE
Active strength
100 1/1
Pharmacologic classes
Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct73152-075IInactivated by FDA2026-08-07
excluded packagepackage73152-07573152-075-01IInactivated by FDA2026-08-07
excluded packagepackage73152-07573152-075-05IInactivated by FDA2026-08-07

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 · 45 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 packagepackage73152-075-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage73152-075-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73152-075-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73152-075-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73152-075-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73152-075-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73152-075-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73152-075-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73152-075-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73152-075-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73152-075-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73152-075-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73152-075-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73152-075-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73152-075-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73152-075-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73152-075-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73152-075-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage73152-075-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage73152-075-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage73152-075-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage73152-075-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage73152-075-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage73152-075-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage73152-075-058af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage73152-075-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage73152-075-05834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage73152-075-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage73152-075-051332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage73152-075-011332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210215-001AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210215-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-104b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210215-001AMANTADINE HYDROCHLORIDE100MGTABLET / ORALAB2020-03-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210215-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210215-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210215-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210215-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210215-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210215-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210215-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210215-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210215-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210215-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210215-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210215-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210215-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210215-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210215-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210215-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210215-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210215-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210215-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210215-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210215-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210215-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210215-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210215-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210215-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210215-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210215-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210215-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210215-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210215-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210215-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210215-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210215-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210215-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210215-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210215-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210215-001AB1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
519d6abc-639d-2962-cced-abbf8b16aad4Product name720250401
82f46845-b4c7-48da-a389-ba5721b956c9Product name220250325
d2c037c0-5ebf-d224-252f-2549922c21c7Product name720240208
b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721Product name220220224
14e11aaf-885f-472f-a02a-c6a3f28df907Product name120180515
82f46845-b4c7-48da-a389-ba5721b956c9Product name120171103

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73152-075-012023-01-30C16284748780-1f386c649-cc21-0266-e053-dadaa90a7c1aAMANTADINE HYDROCHLORIDE TABLET
73152-075-052023-01-30C16284748780-1f386c649-cc21-0266-e053-dadaa90a7c1aAMANTADINE HYDROCHLORIDE TABLET

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73152-075-01Amantadine Hydrochloride100 in 1 BOTTLETABLET1002
73152-075-05Amantadine Hydrochloride500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73152-075-01EA - Each73152-075c3dafb96-156b-4281-91f8-cb9707a6977212021-10-08
73152-075-05EA - Each73152-0753fc06d6d-5635-4a03-8c9e-adf1bed6be7512021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73152-075AMANTADINE HYDROCHLORIDE TABLET [ATHEM LLC]2Legacy NDC, 2 package rows20210220_5ae327cf-8946-4682-9025-64653673e367.zip

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
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEMarlex Pharmaceuticals Inc25af52ee-9b29-4c07-a383-62d4537b63e02025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210215
application number: ANDA210215

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849395amantadine HCl 100 MG Oral TabletPSN5ae327cf-8946-4682-9025-64653673e3672
849395amantadine hydrochloride 100 MG Oral TabletSCD5ae327cf-8946-4682-9025-64653673e3672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73152-075-0173152007501100 TABLET in 1 BOTTLE (73152-075-01) 100 tablet2021-02-190000-00-00NoNoCurrent
73152-075-0573152007505500 TABLET in 1 BOTTLE (73152-075-05) 500 tablet2021-02-190000-00-00NoNoCurrent