Milnacipran Hydrochloride
- Product NDC
- 51991-036
- 11-digit product format
- 519910036
- Labeler code
- 51991
- Product ID
- 51991-036_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
- 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
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| A205071-001 | AB |
| A205071-002 | AB |
| A205071-003 | AB |
| A205071-004 | AB |
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 | 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… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205071-001 | MILNACIPRAN HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2016-01-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205071-002 | MILNACIPRAN HYDROCHLORIDE | 25MG | TABLET / ORAL | 2016-01-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205071-003 | MILNACIPRAN HYDROCHLORIDE | 50MG | TABLET / ORAL | 2016-01-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205071-004 | MILNACIPRAN HYDROCHLORIDE | 100MG | TABLET / ORAL | 2016-01-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205071-001 | MILNACIPRAN HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2016-01-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205071-002 | MILNACIPRAN HYDROCHLORIDE | 25MG | TABLET / ORAL | 2016-01-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205071-003 | MILNACIPRAN HYDROCHLORIDE | 50MG | TABLET / ORAL | 2016-01-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205071-004 | MILNACIPRAN HYDROCHLORIDE | 100MG | TABLET / ORAL | 2016-01-27 | 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 | A205071-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205071-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205071-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205071-004 | AB | 1 | 011fe1cb6892… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A205071-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A205071-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A205071-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A205071-004 | AB | 1 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Milnacipran Hydrochloride
- 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#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e39b4890-99e4-4e48-9f45-978d5ac9f402 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7a197179-317f-1516-8da2-c7f3df29602a | Product name | 4 | 20250423 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51991-036-06 | Milnacipran Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51991-036-06 | EA - Each | 51991-036 | f8cb88a2-ba94-49c1-9242-f292c3aebed7 | 1 | 2026-04-20 |
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 | Breckenridge Pharmaceutical, Inc. | e39b4890-99e4-4e48-9f45-978d5ac9f402 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 205071 ANDA205071 51991-036 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 833135 | milnacipran HCl 100 MG Oral Tablet | PSN | e39b4890-99e4-4e48-9f45-978d5ac9f402 | 3 |
| 833141 | milnacipran HCl 12.5 MG Oral Tablet | PSN | e39b4890-99e4-4e48-9f45-978d5ac9f402 | 3 |
| 833147 | milnacipran HCl 25 MG Oral Tablet | PSN | e39b4890-99e4-4e48-9f45-978d5ac9f402 | 3 |
| 833144 | milnacipran HCl 50 MG Oral Tablet | PSN | e39b4890-99e4-4e48-9f45-978d5ac9f402 | 3 |
| 833135 | milnacipran hydrochloride 100 MG Oral Tablet | SCD | e39b4890-99e4-4e48-9f45-978d5ac9f402 | 3 |
| 833141 | milnacipran hydrochloride 12.5 MG Oral Tablet | SCD | e39b4890-99e4-4e48-9f45-978d5ac9f402 | 3 |
| 833147 | milnacipran hydrochloride 25 MG Oral Tablet | SCD | e39b4890-99e4-4e48-9f45-978d5ac9f402 | 3 |
| 833144 | milnacipran hydrochloride 50 MG Oral Tablet | SCD | e39b4890-99e4-4e48-9f45-978d5ac9f402 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51991-036-06 | 51991003606 | 60 TABLET in 1 BOTTLE (51991-036-06) | 60 tablet | 2026-03-19 | No | No | Current |