Home NDC 65162-094 Milnacipran HCl
Product NDC 65162-094
11-digit product format 651620094
Labeler code 65162
Product ID 65162-094_ba8b4064-0e7b-4ace-863f-764584d538cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Milnacipran HCl
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA205081
Marketing category ANDA
Marketing start 2014-01-31
Marketing end 0000-00-00
Substance MILNACIPRAN HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205081-001 MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2016-04-22 A205081-002 MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-04-22 A205081-003 MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-04-22 A205081-004 MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-04-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 172 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 2026-09-14 22:38:34 2026-08 A205081-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2016-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205081-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205081-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205081-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-04-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205081-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2016-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205081-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205081-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205081-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-04-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205081-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2016-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205081-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205081-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205081-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205081-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205081-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205081-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205081-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205081-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205081-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205081-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205081-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205081-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205081-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205081-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205081-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205081-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205081-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205081-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205081-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205081-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205081-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205081-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205081-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205081-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205081-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205081-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205081-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205081-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205081-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205081-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205081-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-04-22 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Milnacipran HCl
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MILNACIPRAN HYDROCHLORIDE 100 mg/1
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-094 MILNACIPRAN HCL TABLET [AMNEAL PHARMACEUTICALS LLC] 15 Legacy NDC 20240805_eaa14195-1b9c-423c-9412-d2fe0857e39d.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65162-094-06 65162009406 60 TABLET in 1 BOTTLE (65162-094-06) 60 tablet 2014-01-31 0000-00-00 No No Current 65162-094-50 65162009450 500 TABLET in 1 BOTTLE (65162-094-50) 500 tablet 2014-01-31 0000-00-00 No No Current