Home NDC 39328-530 Amantadine Hydrochloride
Product NDC 39328-530
11-digit product format 393280530
Labeler code 39328
Product ID 39328-530_f923b293-f2ac-4116-a122-9524fe748aca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amantadine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Patrin Pharma, Inc.
Application ANDA214178
Marketing category ANDA
Marketing start 2023-08-11
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 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 A214178-001 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214178-001 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.
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 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214178-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 2021-08-20 a50c72e98297…
Observed Orange Book normalized TE history# 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 39328-530-10 Amantadine Hydrochloride 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 3 39328-530-16 Amantadine Hydrochloride 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 3 39328-530-99 Amantadine Hydrochloride 10 in 1 TRAY SOLUTION 10 3 39328-530-99 Amantadine Hydrochloride 10 in 1 CASE SOLUTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39328-530 AMANTADINE HYDROCHLORIDE SOLUTION [PATRIN PHARMA, INC.] 3 Current NDC, 4 package rows 20240523_0fcf5182-a666-4f38-879f-47f19de30dd5.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 39328-530-10 39328053010 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 39328-530-16 39328053016 473 mL in 1 BOTTLE, PLASTIC (39328-530-16) 473 ml 2023-08-11 No No Current 39328-530-99 39328053099 10 TRAY in 1 CASE (39328-530-99) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (39328-530-10) 10 tray 2024-05-08 No No Current