Home NDC 17856-0646-2 AMANTADINE HYDROCHLORIDE
Product NDC 17856-0646
Requested package NDC 17856-0646-2
11-digit product format 178560646
Labeler code 17856
Product ID 17856-0646_34f3552c-a90d-da9a-e063-6294a90a65a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMANTADINE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA074509
Marketing category ANDA
Marketing start 1995-07-17
Substance AMANTADINE HYDROCHLORIDE
Active strength 50 mg/5mL
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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0646 17856-0646-2 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A074509-001 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074509-001 AA
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 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074509-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1995-07-17 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 HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMANTADINE HYDROCHLORIDE 50 mg/5mL
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 849385 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0646-1 AMANTADINE HYDROCHLORIDE 72 in 1 BOX, UNIT-DOSE SOLUTION 72 4 17856-0646-2 AMANTADINE HYDROCHLORIDE 72 in 1 PACKAGE SOLUTION 72 4 17856-0646-3 AMANTADINE HYDROCHLORIDE 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 4 17856-0646-4 AMANTADINE HYDROCHLORIDE 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0646 AMANTADINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.] 4 Current NDC, Legacy NDC, 4 package rows 20250514_6311b46b-23cc-40c1-93c2-f7c92606386f.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 · 4 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 17856-0646-2 17856064602 72 CUP, UNIT-DOSE in 1 PACKAGE (17856-0646-2) / 5 mL in 1 CUP, UNIT-DOSE (17856-0646-4) 2024-04-08 0000-00-00 No No Current