Savella
- Product NDC
- 0456-1550
- 11-digit product format
- 004561550
- Labeler code
- 0456
- Product ID
- 0456-1550_c8829ba6-79a8-476e-8cf1-eb30641287c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- milnacipran hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Allergan, Inc.
- Application
- NDA022256
- Marketing category
- NDA
- Marketing start
- 2009-04-17
- 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
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0456-1550 | 0456-1550-63 | D | Discontinued by firm | 2026-08-10 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| N022256-001 | AB |
| N022256-002 | AB |
| N022256-003 | AB |
| N022256-004 | AB |
Orange Book patents#
| 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.
| 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#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022256-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022256-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022256-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022256-004 | AB | 1 | 011fe1cb6892… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022256-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022256-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022256-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022256-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022256-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022256-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022256-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022256-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022256-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022256-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022256-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022256-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022256-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022256-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022256-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022256-004 | AB | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022256-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022256-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022256-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022256-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022256-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022256-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022256-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022256-004 | AB | 1 | d06236e962d9… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022256-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022256-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022256-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022256-004 | AB | 1 | a50c72e98297… |
Observed Orange Book patent history#
| 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
- Savella
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MILNACIPRAN HYDROCHLORIDE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| RNZ43O5WW5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 833135 | Internal RxNorm lookup |
| 833139 | Internal RxNorm lookup |
| 833141 | Internal RxNorm lookup |
| 833143 | Internal RxNorm lookup |
| 833144 | Internal RxNorm lookup |
| 833146 | Internal RxNorm lookup |
| 833147 | Internal RxNorm lookup |
| 833149 | Internal RxNorm lookup |
| 833150 | Internal RxNorm lookup |
| 833151 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 16a4a314-f97e-4e91-95e9-576a3773d284 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7a197179-317f-1516-8da2-c7f3df29602a | Product name | 4 | 20250423 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0456-1550-11 | Savella | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 39 | |
| 0456-1550-60 | Savella | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 39 | |
| 0456-1550-63 | Savella | 10 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 10 | 39 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0456-1550-60 | EA - Each | 0456-1550 | 80bd096c-a36d-4727-8e17-4e102d39ac72 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0456-1550 | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [ALLERGAN, INC.] | 36 | Current NDC, Legacy NDC, 3 package rows | 20240605_16a4a314-f97e-4e91-95e9-576a3773d284.zip |
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.
| 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 | 022256 NDA022256 |
| Savella | MILNACIPRAN HYDROCHLORIDE | Cardinal Health 107, LLC | 8b720a1e-034b-4583-b80d-105a794cce74 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | 022256 NDA022256 |
| Savella | MILNACIPRAN HYDROCHLORIDE | Allergan, Inc. | 16a4a314-f97e-4e91-95e9-576a3773d284 | 2025-09-10 | Boxed warning, Warnings, Adverse reactions | 022256 NDA022256 0456-1550 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 833151 | {5 (milnacipran hydrochloride 12.5 MG Oral Tablet [Savella]) / 8 (milnacipran hydrochloride 25 MG Oral Tablet [Savella]) / 42 (milnacipran hydrochloride 50 MG Oral Tablet [Savella]) } Pack [Savella 4-Week Titration] | BPCK | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833150 | {5 (milnacipran hydrochloride 12.5 MG Oral Tablet) / 8 (milnacipran hydrochloride 25 MG Oral Tablet) / 42 (milnacipran hydrochloride 50 MG Oral Tablet) } Pack | GPCK | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833135 | milnacipran HCl 100 MG Oral Tablet | PSN | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833141 | milnacipran HCl 12.5 MG Oral Tablet | PSN | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833150 | milnacipran HCl 12.5 MG Oral Tablet (5) / milnacipran HCl 25 MG Oral Tablet (8) / milnacipran HCl 50 MG Oral Tablet (42) Pack | PSN | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833147 | milnacipran HCl 25 MG Oral Tablet | PSN | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833144 | milnacipran HCl 50 MG Oral Tablet | PSN | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833139 | Savella 100 MG Oral Tablet | PSN | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833143 | Savella 12.5 MG Oral Tablet | PSN | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833149 | Savella 25 MG Oral Tablet | PSN | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833151 | Savella 4-Week Titration Pack | PSN | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833146 | Savella 50 MG Oral Tablet | PSN | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833139 | milnacipran hydrochloride 100 MG Oral Tablet [Savella] | SBD | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833143 | milnacipran hydrochloride 12.5 MG Oral Tablet [Savella] | SBD | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833149 | milnacipran hydrochloride 25 MG Oral Tablet [Savella] | SBD | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833146 | milnacipran hydrochloride 50 MG Oral Tablet [Savella] | SBD | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833135 | milnacipran hydrochloride 100 MG Oral Tablet | SCD | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833141 | milnacipran hydrochloride 12.5 MG Oral Tablet | SCD | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833147 | milnacipran hydrochloride 25 MG Oral Tablet | SCD | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833144 | milnacipran hydrochloride 50 MG Oral Tablet | SCD | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833139 | Savella 100 MG Oral Tablet | SY | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833143 | Savella 12.5 MG Oral Tablet | SY | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833149 | Savella 25 MG Oral Tablet | SY | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833151 | Savella 4-Week Titration Pack | SY | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833146 | Savella 50 MG Oral Tablet | SY | 16a4a314-f97e-4e91-95e9-576a3773d284 | 39 |
| 833144 | milnacipran HCl 50 MG Oral Tablet | PSN | 8b720a1e-034b-4583-b80d-105a794cce74 | 11 |
| 833146 | Savella 50 MG Oral Tablet | PSN | 8b720a1e-034b-4583-b80d-105a794cce74 | 11 |
| 833146 | milnacipran hydrochloride 50 MG Oral Tablet [Savella] | SBD | 8b720a1e-034b-4583-b80d-105a794cce74 | 11 |
| 833144 | milnacipran hydrochloride 50 MG Oral Tablet | SCD | 8b720a1e-034b-4583-b80d-105a794cce74 | 11 |
| 833146 | Savella 50 MG Oral Tablet | SY | 8b720a1e-034b-4583-b80d-105a794cce74 | 11 |
| 833135 | milnacipran HCl 100 MG Oral Tablet | PSN | d4e56a10-3b29-4270-ab42-60dc74049cc5 | 5 |
| 833144 | milnacipran HCl 50 MG Oral Tablet | PSN | d4e56a10-3b29-4270-ab42-60dc74049cc5 | 5 |
| 833139 | Savella 100 MG Oral Tablet | PSN | d4e56a10-3b29-4270-ab42-60dc74049cc5 | 5 |
| 833146 | Savella 50 MG Oral Tablet | PSN | d4e56a10-3b29-4270-ab42-60dc74049cc5 | 5 |
| 833139 | milnacipran hydrochloride 100 MG Oral Tablet [Savella] | SBD | d4e56a10-3b29-4270-ab42-60dc74049cc5 | 5 |
| 833146 | milnacipran hydrochloride 50 MG Oral Tablet [Savella] | SBD | d4e56a10-3b29-4270-ab42-60dc74049cc5 | 5 |
| 833135 | milnacipran hydrochloride 100 MG Oral Tablet | SCD | d4e56a10-3b29-4270-ab42-60dc74049cc5 | 5 |
| 833144 | milnacipran hydrochloride 50 MG Oral Tablet | SCD | d4e56a10-3b29-4270-ab42-60dc74049cc5 | 5 |
| 833139 | Savella 100 MG Oral Tablet | SY | d4e56a10-3b29-4270-ab42-60dc74049cc5 | 5 |
| 833146 | Savella 50 MG Oral Tablet | SY | d4e56a10-3b29-4270-ab42-60dc74049cc5 | 5 |
| 833135 | milnacipran HCl 100 MG Oral Tablet | PSN | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833147 | milnacipran HCl 25 MG Oral Tablet | PSN | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833147 | milnacipran HCl 25 MG Oral Tablet | PSN | 08214b30-3dab-4621-a6c0-6bb68529dee3 | 1 |
| 833144 | milnacipran HCl 50 MG Oral Tablet | PSN | 08214b30-3dab-4621-a6c0-6bb68529dee3 | 1 |
| 833144 | milnacipran HCl 50 MG Oral Tablet | PSN | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833139 | Savella 100 MG Oral Tablet | PSN | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833149 | Savella 25 MG Oral Tablet | PSN | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833149 | Savella 25 MG Oral Tablet | PSN | 08214b30-3dab-4621-a6c0-6bb68529dee3 | 1 |
| 833146 | Savella 50 MG Oral Tablet | PSN | 08214b30-3dab-4621-a6c0-6bb68529dee3 | 1 |
| 833146 | Savella 50 MG Oral Tablet | PSN | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833139 | milnacipran hydrochloride 100 MG Oral Tablet [Savella] | SBD | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833149 | milnacipran hydrochloride 25 MG Oral Tablet [Savella] | SBD | 08214b30-3dab-4621-a6c0-6bb68529dee3 | 1 |
| 833149 | milnacipran hydrochloride 25 MG Oral Tablet [Savella] | SBD | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833146 | milnacipran hydrochloride 50 MG Oral Tablet [Savella] | SBD | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833146 | milnacipran hydrochloride 50 MG Oral Tablet [Savella] | SBD | 08214b30-3dab-4621-a6c0-6bb68529dee3 | 1 |
| 833135 | milnacipran hydrochloride 100 MG Oral Tablet | SCD | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833147 | milnacipran hydrochloride 25 MG Oral Tablet | SCD | 08214b30-3dab-4621-a6c0-6bb68529dee3 | 1 |
| 833147 | milnacipran hydrochloride 25 MG Oral Tablet | SCD | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833144 | milnacipran hydrochloride 50 MG Oral Tablet | SCD | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833144 | milnacipran hydrochloride 50 MG Oral Tablet | SCD | 08214b30-3dab-4621-a6c0-6bb68529dee3 | 1 |
| 833139 | Savella 100 MG Oral Tablet | SY | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833149 | Savella 25 MG Oral Tablet | SY | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833149 | Savella 25 MG Oral Tablet | SY | 08214b30-3dab-4621-a6c0-6bb68529dee3 | 1 |
| 833146 | Savella 50 MG Oral Tablet | SY | 9b3d078b-d12f-47ef-baa4-35b88b090ed4 | 1 |
| 833146 | Savella 50 MG Oral Tablet | SY | 08214b30-3dab-4621-a6c0-6bb68529dee3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0456-1550-11 | 00456155011 | 10 in 1 BLISTER PACK | Historical | |||||
| 0456-1550-60 | 00456155060 | 60 TABLET, FILM COATED in 1 BOTTLE (0456-1550-60) | 2009-04-17 | 0000-00-00 | No | No | Current | |
| 0456-1550-63 | 00456155063 | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0456-1550-63) > 10 TABLET, FILM COATED in 1 BLISTER PACK (0456-1550-11) | 10 blister pack | 2009-04-17 | 0000-00-00 | No | No | Current |