Trecator (Page 3 of 3)

HOW SUPPLIED

Trecator^® (ethionamide tablets, USP) are supplied in bottles of 100 tablets as follows:

250 mg, orange film-coated tablet marked “W” on one side and “4117” on reverse side, NDC 0008-4117-01.

Store at controlled room temperature 20 ° to 25 °C (68 ° to 77 °F). Dispense in a tight container.

REFERENCES

1.

Feigin, R.D., and Cherry, J.D.: Textbook of Pediatric Infectious Diseases, 2nd Edition. Philadelphia, W.B. Saunders Co., 1987, pp. 1371–1372.

2.

Nelson, W.E., Behrman, R.E., Vaughan, V.C. (eds.): Nelson Textbook of Pediatrics, 13th edition. Philadelphia, W.B. Saunders Co., 1987, p.636.

3.

Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children, Am J Respiratory and Critical Care Medicine, 149:1359–1374, 1994.

4.

Peloquin, CA: Pharmacology of the Antimycobacterial Drugs, Med Clin North Am 77(6): 1230–1262, 1993.

5.

American Thoracic Society. Am J Respir Crit Care Med 1997;156:S1–S25.

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com.

LAB-0685-8.0
Revised: 08/2023

Principal Display Panel — 250 mg Tablet Bottle Label

Pfizer

NDC 0008-4117-01

Trecator^®
(ethionamide tablets, USP)
tablets

250 mg

SEALED FOR
YOUR PROTECTION

100 Tablets
Rx only

TRECATOR ethionamide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0008-4117 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETHIONAMIDE (ETHIONAMIDE) ETHIONAMIDE 250 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE

Product Characteristics Color ORANGE (ORANGE) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code W;4117 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0008-4117-01 100 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA013026 11/08/2004

Labeler — Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. (113008515)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Manufacturing Deutschland GmbH		341970073	ANALYSIS (0008-4117), LABEL (0008-4117), MANUFACTURE (0008-4117), PACK (0008-4117)

Revised: 09/2023 Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.