Home DailyMed 65c821d7-e8f6-49c3-bc31-82701e550d29 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:56:31 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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 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 · 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 N022256-001 SAVELLA 12.5MG TABLET / ORAL AB RLD 2009-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022256-002 SAVELLA 25MG TABLET / ORAL AB RLD 2009-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022256-003 SAVELLA 50MG TABLET / ORAL AB RLD, RS 2009-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022256-004 SAVELLA 100MG TABLET / ORAL AB RLD 2009-01-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022256-001 SAVELLA 12.5MG TABLET / ORAL AB RLD 2009-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022256-002 SAVELLA 25MG TABLET / ORAL AB RLD 2009-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022256-003 SAVELLA 50MG TABLET / ORAL AB RLD, RS 2009-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022256-004 SAVELLA 100MG TABLET / ORAL AB RLD 2009-01-14 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 9 · 340 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022256-001 7994220 2029-09-19 U-819 2011-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022256-002 7994220 2029-09-19 U-819 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022256-003 7994220 2029-09-19 U-819 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022256-004 7994220 2029-09-19 U-819 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022256-001 7994220 2029-09-19 U-819 2011-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022256-002 7994220 2029-09-19 U-819 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022256-003 7994220 2029-09-19 U-819 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022256-004 7994220 2029-09-19 U-819 caaa826d4ba7…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…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.