Home NDC 60432-093-16 Amantadine Hydrochloride
Product NDC 60432-093
Requested package NDC 60432-093-16
11-digit product format 604320093
Labeler code 60432
Product ID 60432-093_ccea7133-72cd-407f-813f-18a1107aba10
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amantadine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Morton Grove Pharmaceuticals, Inc.
Application ANDA075060
Marketing category ANDA
Marketing start 1998-12-24
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 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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 A075060-001 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 1998-12-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075060-001 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 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 1998-12-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 1998-12-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 1998-12-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 1998-12-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 1998-12-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 1998-12-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 1998-12-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 1998-12-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA 1998-12-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1998-12-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1998-12-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1998-12-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1998-12-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1998-12-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL AA RS 1998-12-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075060-001 AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1998-12-24 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Amantadine Hydrochloride ACTIVE INGREDIENT M6Q1EO9TD0 AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.] 5 Amantadine ACTIVE MOIETY BF4C9Z1J53 AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.] 5 Anhydrous Citric Acid INACTIVE INGREDIENT XF417D3PSL AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.] 5 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.] 5 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.] 5 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.] 5 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.] 5 Sorbitol INACTIVE INGREDIENT 506T60A25R AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.] 5 Trisodium Citrate Dihydrate INACTIVE INGREDIENT B22547B95K AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.] 5 Water INACTIVE INGREDIENT 059QF0KO0R AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.] 5 AMANTADINE HYDROCHLORIDE ACTIVE INGREDIENT M6Q1EO9TD0 AMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 AMANTADINE ACTIVE MOIETY BF4C9Z1J53 AMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP AMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T AMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH AMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY AMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR AMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R AMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60432-093 AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.] 6 Legacy NDC 20181222_c446aed2-1add-4b09-9cc2-69ab95ae12d2.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 Marketing end Sample Exclude flag Status 60432-093-16 60432009316 473 mL in 1 BOTTLE, PLASTIC (60432-093-16) 473 ml 1998-12-24 0000-00-00 No No Current