Home NDC 62135-011 Amantadine Hydrochloride
Product NDC 62135-011
11-digit product format 621350011
Labeler code 62135
Product ID 62135-011_45c62a1b-f162-d3cb-e063-6394a90a7dbf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amantadine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA074028
Marketing category ANDA
Marketing start 1993-06-28
Substance AMANTADINE HYDROCHLORIDE
Active strength 100 mg/10mL
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 A074028-001 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074028-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 100 mg/10mL
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 62135-011-24 Amantadine Hydrochloride 10 in 1 TRAY SOLUTION 10 5 62135-011-24 Amantadine Hydrochloride 2 in 1 BOX SOLUTION 2 5 62135-011-59 Amantadine Hydrochloride 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-011 AMANTADINE HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC] 4 Current NDC, 3 package rows 20240524_52aa093c-82cc-4d81-b072-86a2b8adc9c5.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 · 2 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 62135-011-24 62135001124 2 TRAY in 1 BOX (62135-011-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (62135-011-59) 2 tray 1993-06-28 No No Current 62135-011-59 62135001159 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical