Home NDC 60760-779 Amantadine Hydrochloride
Product NDC 60760-779
11-digit product format 607600779
Labeler code 60760
Product ID 60760-779_3dd7e808-e0ec-8514-e063-6394a90a9f34
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amantadine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler ST. MARY'S MEDICAL PARK PHARMACY
Application ANDA212044
Marketing category ANDA
Marketing start 2020-05-21
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 A212044-001 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212044-001 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.
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 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212044-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2020-05-21 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 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 60760-779-30 Amantadine Hydrochloride 30 in 1 BOTTLE, PLASTIC CAPSULE 30 1
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 Units Marketing start Sample Exclude flag Status 60760-779-30 60760077930 30 CAPSULE in 1 BOTTLE, PLASTIC (60760-779-30) 30 capsule 2025-08-26 No No Current