Home NDC 68462-765 Milnacipran Hydrochloride
Product NDC 68462-765
11-digit product format 684620765
Labeler code 68462
Product ID 68462-765_97a7eb14-fa99-40e4-91c2-be5b34f5e203
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name milnacipran hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application NDA022256
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2026-03-19
Substance MILNACIPRAN HYDROCHLORIDE
Active strength 50 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 1 .
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 N022256-001 SAVELLA MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL AB RLD 2009-01-14 N022256-002 SAVELLA MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL AB RLD 2009-01-14 N022256-003 SAVELLA MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL AB RLD, RS 2009-01-14 N022256-004 SAVELLA MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL AB RLD 2009-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022256-001 7994220 2029-09-19 U-819 2011-09-01 N022256-002 7994220 2029-09-19 U-819 N022256-003 7994220 2029-09-19 U-819 N022256-004 7994220 2029-09-19 U-819
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 · 164 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 2026-02-19 14:30 UTC 2026-02 N022256-001 SAVELLA 12.5MG TABLET / ORAL AB RLD 2009-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022256-002 SAVELLA 25MG TABLET / ORAL AB RLD 2009-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022256-003 SAVELLA 50MG TABLET / ORAL AB RLD, RS 2009-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022256-004 SAVELLA 100MG TABLET / ORAL AB RLD 2009-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022256-001 SAVELLA 12.5MG TABLET / ORAL RLD 2009-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022256-002 SAVELLA 25MG TABLET / ORAL RLD 2009-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022256-003 SAVELLA 50MG TABLET / ORAL RLD, RS 2009-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022256-004 SAVELLA 100MG TABLET / ORAL RLD 2009-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022256-001 SAVELLA 12.5MG TABLET / ORAL RLD 2009-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022256-002 SAVELLA 25MG TABLET / ORAL RLD 2009-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022256-003 SAVELLA 50MG TABLET / ORAL RLD, RS 2009-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022256-004 SAVELLA 100MG TABLET / ORAL RLD 2009-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022256-001 SAVELLA 12.5MG TABLET / ORAL AB RLD 2009-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022256-002 SAVELLA 25MG TABLET / ORAL AB RLD 2009-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022256-003 SAVELLA 50MG TABLET / ORAL AB RLD, RS 2009-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022256-004 SAVELLA 100MG TABLET / ORAL AB RLD 2009-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022256-001 SAVELLA 12.5MG TABLET / ORAL AB RLD 2009-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022256-002 SAVELLA 25MG TABLET / ORAL AB RLD 2009-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022256-003 SAVELLA 50MG TABLET / ORAL AB RLD, RS 2009-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022256-004 SAVELLA 100MG TABLET / ORAL AB RLD 2009-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022256-001 SAVELLA 12.5MG TABLET / ORAL AB RLD 2009-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022256-002 SAVELLA 25MG TABLET / ORAL AB RLD 2009-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022256-003 SAVELLA 50MG TABLET / ORAL AB RLD, RS 2009-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022256-004 SAVELLA 100MG TABLET / ORAL AB RLD 2009-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022256-001 SAVELLA 12.5MG TABLET / ORAL AB RLD 2009-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022256-002 SAVELLA 25MG TABLET / ORAL AB RLD 2009-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022256-003 SAVELLA 50MG TABLET / ORAL AB RLD, RS 2009-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022256-004 SAVELLA 100MG TABLET / ORAL AB RLD 2009-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022256-001 SAVELLA 12.5MG TABLET / ORAL RLD 2009-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022256-002 SAVELLA 25MG TABLET / ORAL RLD 2009-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022256-003 SAVELLA 50MG TABLET / ORAL RLD, RS 2009-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022256-004 SAVELLA 100MG TABLET / ORAL RLD 2009-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022256-001 SAVELLA 12.5MG TABLET / ORAL AB RLD 2009-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022256-002 SAVELLA 25MG TABLET / ORAL AB RLD 2009-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022256-003 SAVELLA 50MG TABLET / ORAL AB RLD, RS 2009-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022256-004 SAVELLA 100MG TABLET / ORAL AB RLD 2009-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022256-001 SAVELLA 12.5MG TABLET / ORAL AB RLD 2009-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022256-002 SAVELLA 25MG TABLET / ORAL AB RLD 2009-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022256-003 SAVELLA 50MG TABLET / ORAL AB RLD, RS 2009-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022256-004 SAVELLA 100MG TABLET / ORAL AB RLD 2009-01-14 d06236e962d9…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 9 · 332 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022256-001 7994220 2029-09-19 U-819 2011-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022256-002 7994220 2029-09-19 U-819 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022256-003 7994220 2029-09-19 U-819 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022256-004 7994220 2029-09-19 U-819 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022256-001 7994220 2029-09-19 U-819 2011-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022256-002 7994220 2029-09-19 U-819 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022256-003 7994220 2029-09-19 U-819 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022256-004 7994220 2029-09-19 U-819 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022256-001 7994220 2029-09-19 U-819 2011-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022256-002 7994220 2029-09-19 U-819 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022256-003 7994220 2029-09-19 U-819 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022256-004 7994220 2029-09-19 U-819 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022256-001 7994220 2029-09-19 U-819 2011-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022256-002 7994220 2029-09-19 U-819 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022256-003 7994220 2029-09-19 U-819 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022256-004 7994220 2029-09-19 U-819 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022256-001 7994220 2029-09-19 U-819 2011-09-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022256-002 7994220 2029-09-19 U-819 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022256-003 7994220 2029-09-19 U-819 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022256-004 7994220 2029-09-19 U-819 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022256-001 7994220 2029-09-19 U-819 2011-09-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022256-002 7994220 2029-09-19 U-819 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022256-003 7994220 2029-09-19 U-819 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022256-004 7994220 2029-09-19 U-819 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022256-001 7994220 2029-09-19 U-819 2011-09-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022256-002 7994220 2029-09-19 U-819 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022256-003 7994220 2029-09-19 U-819 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022256-004 7994220 2029-09-19 U-819 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022256-001 7994220 2029-09-19 U-819 2011-09-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022256-002 7994220 2029-09-19 U-819 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022256-003 7994220 2029-09-19 U-819 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022256-004 7994220 2029-09-19 U-819 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022256-001 7994220 2029-09-19 U-819 2011-09-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022256-002 7994220 2029-09-19 U-819 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022256-003 7994220 2029-09-19 U-819 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022256-004 7994220 2029-09-19 U-819 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022256-001 7994220 2029-09-19 U-819 2011-09-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022256-002 7994220 2029-09-19 U-819 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022256-003 7994220 2029-09-19 U-819 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022256-004 7994220 2029-09-19 U-819 d06236e962d9…
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 50 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68462-765-60 Milnacipran Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 4
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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Milnacipran Hydrochloride MILNACIPRAN HYDROCHLORIDE Glenmark Pharmaceuticals Inc., USA b66b1850-0d2a-41d6-b0ad-c676166394c7 2026-03-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022256 application number: NDA022256 ndc (product): 68462-765 Savella MILNACIPRAN HYDROCHLORIDE Cardinal Health 107, LLC 8b720a1e-034b-4583-b80d-105a794cce74 2026-01-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022256 application number: NDA022256 Savella MILNACIPRAN HYDROCHLORIDE Allergan, Inc. 16a4a314-f97e-4e91-95e9-576a3773d284 2025-09-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022256 application number: NDA022256
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68462-765-60 68462076560 60 TABLET, FILM COATED in 1 BOTTLE (68462-765-60) 2026-03-19 No No Current