Home NDC 69452-142-30 Amantadine HCl
Product NDC 69452-142
Requested package NDC 69452-142-30
11-digit product format 694520142
Labeler code 69452
Product ID 69452-142_372af940-7fe9-4525-e063-6294a90ab417
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMANTADINE HYDROCHLORIDE
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Bionpharma Inc.
Application ANDA078720
Marketing category ANDA
Marketing start 2016-08-15
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 1 .
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 A078720-001 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078720-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2008-05-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2008-05-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2008-05-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2008-05-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Amantadine HCl
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69452-142-20 Amantadine HCl 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 7 69452-142-30 Amantadine HCl 500 in 1 BOTTLE CAPSULE, LIQUID FILLED 500 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMANTADINE HYDROCHLORIDE ACTIVE INGREDIENT M6Q1EO9TD0 AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 AMANTADINE ACTIVE MOIETY BF4C9Z1J53 AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 MANNITOL INACTIVE INGREDIENT 3OWL53L36A AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] 3 AMANTADINE HYDROCHLORIDE ACTIVE INGREDIENT M6Q1EO9TD0 AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2 AMANTADINE ACTIVE MOIETY BF4C9Z1J53 AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVKARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-142 AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BIONPHARMA INC.] 6 Current NDC, Legacy NDC, 2 package rows 20250426_d6ca4d20-72c5-496c-9ac7-1f5cb407a742.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 Marketing start Marketing end Sample Exclude flag Status 69452-142-30 69452014230 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-142-30) 2016-08-15 0000-00-00 No No Current