Home NDC 46708-246 amantadine
Product NDC 46708-246
11-digit product format 467080246
Labeler code 46708
Product ID 46708-246_db464488-fe29-445d-b8c1-b93554371798
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amantadine
Dosage form CAPSULE
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA208966
Marketing category ANDA
Marketing start 2017-06-22
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 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208966-001 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208966-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208966-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-21 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base amantadine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMANTADINE HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M6Q1EO9TD0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849389 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 46708-246-30 2023-02-01 Amantadine Hydrochloride Capsules, USP Rx only 46708-246-31 2023-02-01 Amantadine Hydrochloride Capsules, USP Rx only 46708-246-71 2023-02-01 Amantadine Hydrochloride Capsules, USP Rx only 46708-246-91 2023-02-01 Amantadine Hydrochloride Capsules, USP Rx only 46708-246-30 2023-01-30 Amantadine Hydrochloride Capsules, USP Rx only 46708-246-31 2023-01-30 Amantadine Hydrochloride Capsules, USP Rx only 46708-246-71 2023-01-30 Amantadine Hydrochloride Capsules, USP Rx only 46708-246-91 2023-01-30 Amantadine Hydrochloride Capsules, USP Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-246-30 amantadine 30 in 1 BOTTLE CAPSULE 30 3 46708-246-31 amantadine 100 in 1 BOTTLE CAPSULE 100 3 46708-246-71 amantadine 500 in 1 BOTTLE CAPSULE 500 3 46708-246-91 amantadine 1000 in 1 BOTTLE CAPSULE 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-246 AMANTADINE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 4 package rows 20230202_d8887814-3e56-447e-8bc3-add1861e0cf7.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46708-246-30 46708024630 30 CAPSULE in 1 BOTTLE (46708-246-30) 30 capsule 2017-06-22 0000-00-00 No No Current 46708-246-31 46708024631 100 CAPSULE in 1 BOTTLE (46708-246-31) 100 capsule 2017-06-22 0000-00-00 No No Current 46708-246-71 46708024671 500 CAPSULE in 1 BOTTLE (46708-246-71) 500 capsule 2017-06-22 0000-00-00 No No Current 46708-246-91 46708024691 1000 CAPSULE in 1 BOTTLE (46708-246-91) 1000 capsule 2017-06-22 0000-00-00 No No Current