Home NDC 0121-0646 AMANTADINE HYDROCHLORIDE
Product NDC 0121-0646
11-digit product format 001210646
Labeler code 0121
Product ID 0121-0646_0d5911e6-e5b6-4013-98ec-773d9ec62dec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMANTADINE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0121-0646-10 AMANTADINE HYDROCHLORIDE 10 in 1 CASE SOLUTION 10 11 0121-0646-10 AMANTADINE HYDROCHLORIDE 10 in 1 TRAY SOLUTION 10 11 0121-0646-16 AMANTADINE HYDROCHLORIDE 473 mL in 1 BOTTLE SOLUTION 473 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMANTADINE HYDROCHLORIDE ACTIVE INGREDIENT M6Q1EO9TD0 AMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 AMANTADINE ACTIVE MOIETY BF4C9Z1J53 AMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP AMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T AMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH AMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R AMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R AMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 4 AMANTADINE HYDROCHLORIDE ACTIVE INGREDIENT M6Q1EO9TD0 AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] 2 AMANTADINE ACTIVE MOIETY BF4C9Z1J53 AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] 2 WATER INACTIVE INGREDIENT 059QF0KO0R AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0646 AMANTADINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 10 Current NDC, Legacy NDC, 3 package rows 20241114_be411327-5ac7-46df-b5e4-32a11b419b15.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 0121-0646-10 00121064610 10 TRAY in 1 CASE (0121-0646-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE 10 tray 1995-07-17 0000-00-00 No No Current 0121-0646-16 00121064616 473 mL in 1 BOTTLE (0121-0646-16) 473 ml 1995-07-17 0000-00-00 No No Current