Haloperidol Decanoate Injection
FDA Label NDC 70771-1853

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Haloperidol Decanoate (NDC 70771-1853). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

50 mg Per mL Carton Label (04562fb6 450e 4345 Ac35 6bc8c940682a 01)

50 mg Per mL Carton Label (04562fb6 450e 4345 Ac35 6bc8c940682a 01)

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

250 mg Per 5 mL Carton Label (04562fb6 450e 4345 Ac35 6bc8c940682a 02)

250 mg Per 5 mL Carton Label (04562fb6 450e 4345 Ac35 6bc8c940682a 02)

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

100 mg Per mL Carton Label (04562fb6 450e 4345 Ac35 6bc8c940682a 03)

100 mg Per mL Carton Label (04562fb6 450e 4345 Ac35 6bc8c940682a 03)

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

500 mg Per 5 mL Carton Label (04562fb6 450e 4345 Ac35 6bc8c940682a 04)

500 mg Per 5 mL Carton Label (04562fb6 450e 4345 Ac35 6bc8c940682a 04)

* Please review the disclaimer below.