Home NDC 35356-545 Savella
Product NDC 35356-545
11-digit product format 353560545
Labeler code 35356
Product ID 35356-545_372ea4d8-8d8f-4090-9d46-8e7322f86ac6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name milnacipran hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Application NDA022256
Marketing category NDA
Marketing start 2011-11-17
Marketing end 0000-00-00
Substance MILNACIPRAN HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 35356-545-60 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 35356-545-60 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 35356-545-60 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 35356-545-60 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 35356-545-60 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 35356-545-60 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 35356-545-60 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 35356-545-60 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 35356-545-60 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 35356-545-60 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 35356-545-60 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 35356-545-60 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 35356-545-60 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 35356-545-60 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 35356-545-60 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 35356-545-60 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 35356-545-60 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 35356-545-60 I Inactivated by FDA bd6a592717d7…303034d00443…
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…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded milnacipran hydrochloride ACTIVE INGREDIENT RNZ43O5WW5 SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257 milnacipran ACTIVE MOIETY G56VK1HF36 SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257 carboxymethylcellulose calcium INACTIVE INGREDIENT UTY7PDF93L SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257 colloidal silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257 dibasic calcium phosphate dihydrate INACTIVE INGREDIENT O7TSZ97GEP SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257 FD&C Yellow No. 5 INACTIVE INGREDIENT I753WB2F1M SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257 magnesium stearate INACTIVE INGREDIENT 70097M6I30 SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257 povidone INACTIVE INGREDIENT FZ989GH94E SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257 talc INACTIVE INGREDIENT 7SEV7J4R1U SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3257
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 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 35356-545-60 35356054560 60 TABLET, FILM COATED in 1 BOTTLE (35356-545-60) 2011-11-17 0000-00-00 No No Current