FDA Label for Haloperidol Decanoate
View Indications, Usage & Precautions
Haloperidol Decanoate Product Label
The following document was submitted to the FDA by the labeler of this product Zydus Lifesciences Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Package Label.Principal Display Panel
50 mg/mL Carton (3 vials per carton)
NDC 70771-1851-9
Haloperidol Decanoate
Injection
50 mg/mL*
For Intramuscular Use Only
3 X 1 mL
Single-Dose Vials
Sterile
Rx only
250 mg/5 mL (50 mg/mL) Carton (1 vial per carton)
NDC 70771-1852-1
Haloperidol Decanoate Injection
250 mg/5 mL*
(50 mg/mL)
For Intramuscular Use Only
5 mL
Multiple-Dose Vial
Sterile
Rx only
100 mg/mL Carton (1 vial per carton)
NDC 70771-1853-1
Haloperidol Decanoate Injection
100 mg/mL*
For Intramuscular Use Only
1 mL
Single-Dose Vial
Sterile
Rx only
500 mg/5 mL (100 mg/mL) Carton (1 vial per carton)
NDC 70771-1854-1
Haloperidol Decanoate Injection
500 mg/5 mL*
(100 mg/mL)
For Intramuscular Use Only
5 mL Multiple-Dose Vial
Sterile
Rx only
* Please review the disclaimer below.