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Lilly PACKAGE LABEL - Mounjaro Single-Dose Vial - 5 mg/0.5 mL Dose NDC 0002-1243-01 Mounjaro (tirzepatide) injection 5 mg/0.5 mL Single-dose Vial - discard unused portion Rx Only For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient

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Why These 7 Substances Are Being Reviewed Under section 503A of the Federal Food, Drug, and Cosmetic Act, a compounded human drug product is exempt from new drug approval, labeling, and current good manufacturing practice requirements only if, among other conditions, the bulk drug substance used complies with a USP or National Formulary monograph, is a component of an FDA-approved drug, or appears on the 503A Bulks List