Home NDC 46672-606 amantadine hydrochloride
Product NDC 46672-606
11-digit product format 466720606
Labeler code 46672
Product ID 46672-606_9c6f1329-354f-7321-e053-2995a90a940c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amantadine hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Mikart, LLC
Application ANDA074028
Marketing category ANDA
Marketing start 1993-06-28
Marketing end 0000-00-00
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 2021-12-31
Current FDA listing Historical FDA.report record 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 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 · 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 A074028-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1993-06-28 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMANTADINE HYDROCHLORIDE ACTIVE INGREDIENT M6Q1EO9TD0 AMANTADINE HYDROCHLORIDE SYRUP [MIKART, INC.] 2 AMANTADINE ACTIVE MOIETY BF4C9Z1J53 AMANTADINE HYDROCHLORIDE SYRUP [MIKART, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL AMANTADINE HYDROCHLORIDE SYRUP [MIKART, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T AMANTADINE HYDROCHLORIDE SYRUP [MIKART, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AMANTADINE HYDROCHLORIDE SYRUP [MIKART, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH AMANTADINE HYDROCHLORIDE SYRUP [MIKART, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R AMANTADINE HYDROCHLORIDE SYRUP [MIKART, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R AMANTADINE HYDROCHLORIDE SYRUP [MIKART, INC.] 2
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46672-606-16 46672060616 473 mL in 1 BOTTLE, PLASTIC (46672-606-16) 473 ml 1993-06-28 0000-00-00 No No Current