Quick answers
- What is Trimethobenzamide hydrochloride used for?
- The FDA-approved label (Tigan, Par Health USA, LLC, March 10, 2026) says: “INDICATIONS Tigan ® is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Trimethobenzamide hydrochloride have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Trimethobenzamide hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Trimethobenzamide hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Trimethobenzamide hydrochloride?
- 8 companies list prescription products of Trimethobenzamide hydrochloride in the FDA NDC Directory, including HF Acquisition Co LLC, DBA HealthFirst, BPI Labs LLC and Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..
What Trimethobenzamide hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATIONS Tigan ® is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
— FDA label: Tigan, Par Health USA, LLC, effective March 10, 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.
The label quoted above has no boxed warning.
0 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Capsule |
|---|---|
| Route | Intramuscular · Oral |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Tigan |
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.
- HF Acquisition Co LLC, DBA HealthFirst1 product
- BPI Labs LLC1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Par Health USA, LLC1 product
- Lupin Pharmaceuticals, Inc.1 product
- Henry Schein, Inc.1 product
- Chartwell RX, LLC1 product
- Bryant Ranch Prepack1 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 |
|---|---|---|---|
| NDA017530 TIGAN | Ph Health | July 12, 1974 | 16, latest April 18, 2008 2008: Labeling · 2005: Manufacturing (CMC) · 2005: Manufacturing (CMC) |
Generic approvals (3)
- ANDA076546Lupin · August 20, 2003
- ANDA205950Heritage Pharma Avet · November 21, 2023
- ANDA219606Bpi Labs · October 16, 2025
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) | 860771, 1726680, 1726682 |
|---|---|
| SPL set ID of the quoted label | 7da90678-b229-4ad6-9193-2b8a3e9ba695 |
| FDA labels (SPL) | 8 |
| FDA applications | NDA017530, 3 ANDA |
| Active ingredients (FDA) | TRIMETHOBENZAMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tigan, Par Health USA, LLC, effective March 10, 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 →