Home NDC 0527-1704-05 Amantadine Hydrochloride
Product NDC 0527-1704
Requested package NDC 0527-1704-05
11-digit product format 005271704
Labeler code 0527
Product ID 0527-1704_d2c8dafb-7e51-4cea-a990-77a4ec35509c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amantadine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA078720
Marketing category ANDA
Marketing start 2008-11-01
Marketing end 0000-00-00
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 2021-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 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 · 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 A078720-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 2008-05-29 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMANTADINE HYDROCHLORIDE ACTIVE INGREDIENT M6Q1EO9TD0 AMANTADINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 12 AMANTADINE ACTIVE MOIETY BF4C9Z1J53 AMANTADINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 12 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT AMANTADINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 12 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 AMANTADINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 12 GELATIN INACTIVE INGREDIENT 2G86QN327L AMANTADINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 12 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AMANTADINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 12 MANNITOL INACTIVE INGREDIENT 3OWL53L36A AMANTADINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 12 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU AMANTADINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 12 SORBITOL INACTIVE INGREDIENT 506T60A25R AMANTADINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 12 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A AMANTADINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMANTADINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 12 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F AMANTADINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 12 AMANTADINE HYDROCHLORIDE ACTIVE INGREDIENT M6Q1EO9TD0 AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] 3 AMANTADINE ACTIVE MOIETY BF4C9Z1J53 AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] 3 MANNITOL INACTIVE INGREDIENT 3OWL53L36A AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] 3 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] 3 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] 3 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] 3
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 0527-1704-05 00527170405 500 CAPSULE in 1 BOTTLE (0527-1704-05) 500 capsule 2008-11-01 0000-00-00 No No Current