Home NDC 33342-370-09 Milnacipran Hydrochloride
Product NDC 33342-370
Requested package NDC 33342-370-09
11-digit product format 333420370
Labeler code 33342
Product ID 33342-370_52ad5462-ed80-417a-964f-56ef1fdce3f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Milnacipran Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA210944
Marketing category ANDA
Marketing start 2026-09-15
Substance MILNACIPRAN HYDROCHLORIDE
Active strength 25 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A210944-001 MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2026-09-15 A210944-002 MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL AB 2026-09-15 A210944-003 MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL AB 2026-09-15 A210944-004 MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL AB 2026-09-15
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.
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 2026-10-15 13:18:30 2026-09 A210944-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2026-09-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A210944-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL AB 2026-09-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A210944-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL AB 2026-09-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A210944-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL AB 2026-09-15 c2088c7a36db…
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 Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MILNACIPRAN HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RNZ43O5WW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 833135 Internal RxNorm lookup 833141 Internal RxNorm lookup 833144 Internal RxNorm lookup 833147 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 33342-370-09 33342037009 60 TABLET in 1 BOTTLE (33342-370-09) 60 tablet 2026-09-15 No No Current