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Brand-name prescription medicine

Zolpidem tartrate sublingual

Generic name: Zolpidem tartrate

FDA application holder: PH Health

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Zolpidem tartrate sublingual?
Zolpidem tartrate sublingual is a brand name of Zolpidem tartrate, a prescription medicine. The FDA NDC Directory lists 2 Zolpidem tartrate sublingual products in 2 strengths and forms.
Who makes Zolpidem tartrate sublingual?
PH Health holds the FDA application for Zolpidem tartrate sublingual (ANDA204229, approved September 11, 2017).
Is there a generic or store brand of Zolpidem tartrate sublingual?
Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Zolpidem tartrate sublingual product, 2 of them generic. Ask your pharmacist whether one is right for you.
What do pharmacies pay for Zolpidem tartrate sublingual?
CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Zolpidem tartrate sublingual strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
Has Zolpidem tartrate sublingual been recalled?
No recall linked to Zolpidem tartrate sublingual products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Zolpidem tartrate sublingual is

Each Zolpidem tartrate sublingual product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Zolpidem tartrate · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
zolpidem tartrate 1.75 mg
tablet (sublingual)
Zolpidem tartrate sublingual 1 product, 1 company DailyMed
zolpidem tartrate 3.5 mg
tablet (sublingual)
Zolpidem tartrate sublingual 1 product, 1 company DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Zolpidem tartrate →

FDA approval

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
FDA applications of Zolpidem tartrate sublingual products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
ANDA204229PH HealthSeptember 11, 20172

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.

NADAC per unit for Zolpidem tartrate sublingual, by strength and form
Strength and formGeneric or brandPharmacies pay
zolpidem tartrate 1.75 mg
tablet
Generic: Zolpidem tartrate sublingual $4.92 per tablet
Generic of the same strength and form: $4.92 per tablet
zolpidem tartrate 3.5 mg
tablet
Generic: Zolpidem tartrate sublingual $5.80 per tablet
Generic of the same strength and form: $5.80 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 Zolpidem tartrate sublingual

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Zolpidem tartrate sublingual products.

Recalls

No recall linked to Zolpidem tartrate sublingual products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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