Home NDC 51991-037 Milnacipran Hydrochloride
Product NDC 51991-037
11-digit product format 519910037
Labeler code 51991
Product ID 51991-037_06af9883-25a1-4d2f-849c-a32e43a1324e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Milnacipran Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Breckenridge Pharmaceutical, Inc.
Application ANDA205071
Marketing category ANDA
Marketing start 2026-03-19
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 2027-12-31
Current FDA listing Yes 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 A205071-001 MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2016-01-27 A205071-002 MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-01-27 A205071-003 MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-01-27 A205071-004 MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-01-27
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 A205071-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2016-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205071-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205071-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205071-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-01-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205071-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2016-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205071-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205071-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205071-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-01-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205071-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2016-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205071-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL AB 2016-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205071-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL AB 2016-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205071-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205071-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205071-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205071-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205071-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205071-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205071-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205071-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205071-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205071-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205071-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205071-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205071-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205071-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205071-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205071-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205071-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205071-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205071-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205071-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205071-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205071-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205071-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205071-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205071-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205071-001 MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET / ORAL 2016-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205071-002 MILNACIPRAN HYDROCHLORIDE 25MG TABLET / ORAL 2016-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205071-003 MILNACIPRAN HYDROCHLORIDE 50MG TABLET / ORAL 2016-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205071-004 MILNACIPRAN HYDROCHLORIDE 100MG TABLET / ORAL 2016-01-27 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 Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MILNACIPRAN HYDROCHLORIDE 100 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 51991-037-06 Milnacipran Hydrochloride 60 in 1 BOTTLE TABLET 60 3
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51991-037-06 51991003706 60 TABLET in 1 BOTTLE (51991-037-06) 60 tablet 2026-03-19 No No Current