Quick answers
- What is Levorphanol tartrate used for?
- The FDA-approved label (Levorphanol Tartrate, SpecGx LLC, April 28, 2026) says: “Levorphanol Tartrate Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy ( see WARNINGS ), reserve opioid analgesics, including Levorphanol Tartrate …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Levorphanol tartrate have a boxed warning?
- Yes. The FDA label for Levorphanol Tartrate has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF LEVORPHANOL TARTRATE TABLETS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Levorphanol tartrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Levorphanol tartrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Levorphanol tartrate?
- 7 companies list prescription products of Levorphanol tartrate in the FDA NDC Directory, including Bryant Ranch Prepack, Lannett Company, Inc. and Sun Pharmaceutical Industries, Inc..
What Levorphanol tartrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Levorphanol Tartrate Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy ( see WARNINGS ), reserve opioid analgesics, including Levorphanol Tartrate …
— FDA label: Levorphanol Tartrate, SpecGx LLC, effective April 28, 2026. Read the full label on DailyMed →
The FDA has 8 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. Its heading: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF LEVORPHANOL TARTRATE TABLETS
. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 10 in the FDA NDC Directory |
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 |
|---|---|---|
| levorphanol tartrate 2 mg tablet | Generic | $18.13 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 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.
- Bryant Ranch Prepack2 products
- Lannett Company, Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Acertis Pharmaceuticals, LLC1 product
- Virtus Pharmaceuticals, LLC1 product
- Hikma Pharmaceuticals USA Inc.1 product
- SpecGx LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA074278Hikma · March 31, 2000
- ANDA211484Acertis Pharms · December 13, 2018
- ANDA212024Specgx LLC · December 13, 2019
- ANDA213479Novitium Pharma · July 1, 2020
- ANDA213906Sun Pharm Inds Inc · June 17, 2021
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
| RxCUI (RxNorm) | 197873, 2058845 |
|---|---|
| SPL set ID of the quoted label | 759c7040-0be0-4d17-be97-e467e423eaa8 |
| FDA labels (SPL) | 8 |
| FDA applications | 5 ANDA |
| Active ingredients (FDA) | LEVORPHANOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Levorphanol Tartrate, SpecGx LLC, effective April 28, 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 →