Quick answers
- What is Chlordiazepoxide and amitriptyline hydrochloride used for?
- The FDA-approved label (Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc., March 15, 2026) says: “Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablets occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Chlordiazepoxide and amitriptyline hydrochloride have a boxed warning?
- Yes. The FDA label for Chlordiazepoxide and Amitriptyline Hydrochloride has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Chlordiazepoxide and amitriptyline hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Chlordiazepoxide and amitriptyline hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Chlordiazepoxide and amitriptyline hydrochloride?
- 1 company lists prescription products of Chlordiazepoxide and amitriptyline hydrochloride in the FDA NDC Directory, including Mylan Pharmaceuticals Inc..
What Chlordiazepoxide and amitriptyline hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablets occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. …
— FDA label: Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc., effective March 15, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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 →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 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 |
|---|---|---|
| amitriptyline hydrochloride 14 mg · chlordiazepoxide 5 mg tablet, film coated | Generic | $1.20 per tablet |
NADAC list of November 4, 2026; these prices took effect on August 19, 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.
- Mylan Pharmaceuticals Inc.2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA071297Mylan Pharms Inc · December 10, 1986
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) | 856769, 856792 |
|---|---|
| SPL set ID of the quoted label | 66a756f2-ac77-451c-a19a-08896d73b15c |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | AMITRIPTYLINE / CHLORDIAZEPOXIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc., effective March 15, 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 →