Home NDC 71335-9618 Amantadine Hydrochloride
Product NDC 71335-9618
11-digit product format 713359618
Labeler code 71335
Product ID 71335-9618_a7b3fa7c-2c84-4a3a-ae2a-c0f164078999
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amantadine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA209047
Marketing category ANDA
Marketing start 2017-07-31
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 2027-12-31
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 A209047-001 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209047-001 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 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL BX 2017-06-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL BX 2017-06-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL BX 2017-06-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL BX 2017-06-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL BX 2017-06-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2017-06-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL BX 2017-06-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL BX 2017-06-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL BX 2017-06-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209047-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL BX 2017-06-07 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 2027-12-31 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 71335-9618-1 Amantadine Hydrochloride 20 in 1 BOTTLE CAPSULE 20 103 71335-9618-2 Amantadine Hydrochloride 30 in 1 BOTTLE CAPSULE 30 103 71335-9618-3 Amantadine Hydrochloride 10 in 1 BOTTLE CAPSULE 10 103 71335-9618-4 Amantadine Hydrochloride 14 in 1 BOTTLE CAPSULE 14 103 71335-9618-5 Amantadine Hydrochloride 60 in 1 BOTTLE CAPSULE 60 103 71335-9618-6 Amantadine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-9618 AMANTADINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 6 package rows 20240602_6326d7f5-4c7c-4541-8db1-c582f1525f60.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 Units Marketing start Marketing end Sample Exclude flag Status 71335-9618-1 71335961801 20 CAPSULE in 1 BOTTLE (71335-9618-1) 20 capsule 2026-04-15 0000-00-00 No No Current 71335-9618-2 71335961802 30 CAPSULE in 1 BOTTLE (71335-9618-2) 30 capsule 2026-04-15 0000-00-00 No No Current 71335-9618-3 71335961803 10 CAPSULE in 1 BOTTLE (71335-9618-3) 10 capsule 2024-05-30 0000-00-00 No No Current 71335-9618-4 71335961804 14 CAPSULE in 1 BOTTLE (71335-9618-4) 14 capsule 2026-04-15 0000-00-00 No No Current 71335-9618-5 71335961805 60 CAPSULE in 1 BOTTLE (71335-9618-5) 60 capsule 2022-12-30 0000-00-00 No No Current 71335-9618-6 71335961806 100 CAPSULE in 1 BOTTLE (71335-9618-6) 100 capsule 2026-04-15 No No Current