Quick answers
- What is Milnacipran hydrochloride used for?
- The FDA-approved label (Savella, Cardinal Health 107, LLC, January 26, 2026) says: “SAVELLA is indicated for the management of fibromyalgia. SAVELLA is not approved for use in pediatric patients […]. • SAVELLA ® is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia. • SAVELLA is not approved for use in pediatric patients.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Milnacipran hydrochloride have a boxed warning?
- Yes. The FDA label for Savella has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Milnacipran hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Milnacipran hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Milnacipran hydrochloride?
- 7 companies list prescription products of Milnacipran hydrochloride in the FDA NDC Directory, including Amneal Pharmaceuticals LLC, Macleods Pharmaceuticals Limited and Camber Pharmaceuticals, Inc..
What Milnacipran hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SAVELLA is indicated for the management of fibromyalgia. SAVELLA is not approved for use in pediatric patients […]. • SAVELLA ® is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia. • SAVELLA is not approved for use in pediatric patients.
— FDA label: Savella, Cardinal Health 107, LLC, effective January 26, 2026. Read the full label on DailyMed →
The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
5 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 25 in the FDA NDC Directory |
| Brand names | Savella |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| milnacipran hydrochloride 100 mg tablet | Generic | $2.73 per tablet |
| milnacipran hydrochloride 100 mg tablet, film coated | Generic | $2.73 per tablet |
| milnacipran hydrochloride 100 mg tablet, film coated | Brand: Savella | $8.15 per tablet |
| milnacipran hydrochloride 12.5 mg tablet | Generic | $1.22 per tablet |
| milnacipran hydrochloride 12.5 mg tablet, film coated | Generic | $1.22 per tablet |
| milnacipran hydrochloride 12.5 mg tablet, film coated | Brand: Savella | $8.17 per tablet |
| milnacipran hydrochloride 25 mg tablet | Generic | $2.38 per tablet |
| milnacipran hydrochloride 25 mg tablet, film coated | Generic | $2.38 per tablet |
| milnacipran hydrochloride 25 mg tablet, film coated | Brand: Savella | $8.15 per tablet |
| milnacipran hydrochloride 50 mg tablet | Generic | $2.83 per tablet |
| milnacipran hydrochloride 50 mg tablet, film coated | Generic | $2.83 per tablet |
| milnacipran hydrochloride 50 mg tablet, film coated | Brand: Savella | $8.16 per tablet |
NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amneal Pharmaceuticals LLC4 products
- Macleods Pharmaceuticals Limited4 products
- Camber Pharmaceuticals, Inc.4 products
- Breckenridge Pharmaceutical, Inc.4 products
- Allergan, Inc.4 products
- Glenmark Pharmaceuticals Inc., USA4 products
- Cardinal Health 107, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022256 SAVELLA | Abbvie | January 14, 2009 | 24, latest September 10, 2025 2025: Labeling · 2024: Labeling · 2023: Labeling |
Generic approvals (4)
- ANDA205071Breckenridge · January 27, 2016
- ANDA205081Amneal Pharms · April 22, 2016
- ANDA205147Hetero Labs Ltd V · October 3, 2024
- ANDA210944Macleods Pharms · September 15, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Savella, Cardinal Health 107, LLC, effective January 26, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →