vraylar

Generic: cariprazine

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vraylar
Generic Name cariprazine
Labeler allergan, inc.
Dosage Form KIT
Routes
ORAL
Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 61874-170
Product ID 61874-170_db2154b0-f0c7-403c-95fd-794666e79e30
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204370
Listing Expiration 2026-12-31
Marketing Start 2015-09-17

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61874170
Hyphenated Format 61874-170

Supplemental Identifiers

RxCUI
1667660 1667666 1667668 1667670 1667672 1667674 1667676 1667678 1741746 1741747 2729792 2729794 2729796 2729798
UPC
0361874275308 0361874250305
UNII
F6RJL8B278
NUI
N0000175430

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vraylar (source: ndc)
Generic Name cariprazine (source: ndc)
Application Number NDA204370 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 0.5 mg
  • 0.75 mg
  • 1.5 mg
  • 3 mg
  • 4.5 mg
  • 6 mg
source: label
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied VRAYLAR (cariprazine) capsules are supplied as follows: Capsule Strength Imprint Codes Capsule Color Package Configuration NDC Code 0.5 mg FL 0.5 Ivory to yellow cap and grey to green body Bottle of 30 61874-250-30 0.75 mg FL 0.75 Grey to green cap and blue body Bottle of 30 61874-275-30 1.5 mg FL 1.5 White cap and body Blister pack of 7 61874-115-17 Bottle of 30 61874-115-30 Bottle of 90 61874-115-90 Box of 20 (Hospital Unit Dose) 61874-115-20 3 mg FL 3 Green to blue-green cap and white body Bottle of 30 61874-130-30 Bottle of 90 61874-130-90 Box of 20 (Hospital Unit Dose) 61874-130-20 4.5 mg FL 4.5 Green to blue-green cap and body Bottle of 30 61874-145-30 Bottle of 90 61874-145-90 6 mg FL 6 Purple cap and white body Bottle of 30 61874-160-30 Bottle of 90 61874-160-90 (1) 1.5 mg, (6) 3 mg FL 1.5, FL 3 Mixed Blister pack of 7 61874-170-08 16.2 Storage and Handling Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] . Protect 3 mg and 4.5 mg capsules from light to prevent potential color fading.
  • 16.1 How Supplied VRAYLAR (cariprazine) capsules are supplied as follows: Capsule Strength Imprint Codes Capsule Color Package Configuration NDC Code 0.5 mg FL 0.5 Ivory to yellow cap and grey to green body Bottle of 30 61874-250-30 0.75 mg FL 0.75 Grey to green cap and blue body Bottle of 30 61874-275-30 1.5 mg FL 1.5 White cap and body Blister pack of 7 61874-115-17 Bottle of 30 61874-115-30 Bottle of 90 61874-115-90 Box of 20 (Hospital Unit Dose) 61874-115-20 3 mg FL 3 Green to blue-green cap and white body Bottle of 30 61874-130-30 Bottle of 90 61874-130-90 Box of 20 (Hospital Unit Dose) 61874-130-20 4.5 mg FL 4.5 Green to blue-green cap and body Bottle of 30 61874-145-30 Bottle of 90 61874-145-90 6 mg FL 6 Purple cap and white body Bottle of 30 61874-160-30 Bottle of 90 61874-160-90 (1) 1.5 mg, (6) 3 mg FL 1.5, FL 3 Mixed Blister pack of 7 61874-170-08
  • PRINCIPAL DISPLAY PANEL NDC 61874-115-20 Rx Only Vraylar ® (cariprazine) capsules 1.5 mg per capsule ATTENTION PRESCRIBER: PLEASE DISPENSE MEDICATION GUIDE TO EACH PATIENT. Each capsule contains cariprazine HCl equivalent to 1.5 mg cariprazine base. 20 capsules (2x10-count blister cards). NDC 61874-115-20 Rx Only Vraylar® (cariprazine) capsules 1.5 mg per capsule ATTENTION PRESCRIBER: PLEASE DISPENSE MEDICATION GUIDE TO EACH PATIENT. Each capsule contains cariprazine HCl equivalent to 1.5 mg cariprazine base. 20 capsules (2x10-count blister cards).
  • PRINCIPAL DISPLAY PANEL NDC 61874-130-20 Rx Only Vraylar ® (cariprazine) capsules 3 mg per capsule ATTENTION PRESCRIBER: PLEASE DISPENSE MEDICATION GUIDE TO EACH PATIENT. Each capsule contains cariprazine HCl equivalent to 3 mg cariprazine base. 20 capsules (2x10-count blister cards) NDC 61874-130-20 Rx Only Vraylar® (cariprazine) capsules 3 mg per capsule ATTENTION PRESCRIBER: PLEASE DISPENSE MEDICATION GUIDE TO EACH PATIENT. Each capsule contains cariprazine HCl equivalent to 3 mg cariprazine base. 20 capsules (2x10-count blister cards)
  • PRINCIPAL DISPLAY PANEL NDC 61874-145-30 Rx Only Vraylar ® (cariprazine) capsules 4.5 mg per capsule ATTENTION PRESCRIBER: PLEASE DISPENSE MEDICATION GUIDE TO EACH PATIENT. 30 Capsules NDC 61874-145-30 Rx Only Vraylar® (cariprazine) capsules 4.5 mg per capsule ATTENTION PRESCRIBER: PLEASE DISPENSE MEDICATION GUIDE TO EACH PATIENT. 30 Capsules
  • PRINCIPAL DISPLAY PANEL NDC 61874-160-30 Rx Only Vraylar ® (cariprazine) capsules 6 mg per capsule ATTENTION PRESCRIBER: PLEASE DISPENSE MEDICATION GUIDE TO EACH PATIENT. 30 Capsules NDC 61874-160-30 Rx Only Vraylar® (cariprazine) capsules 6 mg per capsule ATTENTION PRESCRIBER: PLEASE DISPENSE MEDICATION GUIDE TO EACH PATIENT. 30 Capsules
  • PRINCIPAL DISPLAY PANEL NDC 61874-250-30 Rx Only Vraylar ® (cariprazine) capsules 0.5 mg per capsule Dispense the accompanying Medication Guide to each patient. 30 Capsules PRINCIPAL DISPLAY PANEL NDC 61874-250-30 Rx Only Vraylar® (cariprazine) capsules 0.5 mg per capsule Dispense the accompanying Medication Guide to each patient. 30 Capsules
  • PRINCIPAL DISPLAY PANEL NDC 61874-275-30 Rx Only Vraylar ® (cariprazine) capsules 0.75 mg per capsule Dispense the accompanying Medication Guide to each patient. 30 Capsules PRINCIPAL DISPLAY PANEL NDC 61874-275-30 Rx Only Vraylar® (cariprazine) capsules 0.75 mg per capsule Dispense the accompanying Medication Guide to each patient. 30 Capsules
  • PRINCIPAL DISPLAY PANEL NDC 61874-170-08 Rx Only Vraylar ® PRINCIPAL DISPLAY PANEL NDC 61874-170-08 Rx Only Vraylar®
source: label

Packages (0)

No package records.

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Vraylar ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "db2154b0-f0c7-403c-95fd-794666e79e30", "openfda": {"nui": ["N0000175430"], "upc": ["0361874275308", "0361874250305"], "unii": ["F6RJL8B278"], "rxcui": ["1667660", "1667666", "1667668", "1667670", "1667672", "1667674", "1667676", "1667678", "1741746", "1741747", "2729792", "2729794", "2729796", "2729798"], "spl_set_id": ["4b5f7c65-aa2d-452a-b3db-bc85c06ff12f"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Vraylar", "product_id": "61874-170_db2154b0-f0c7-403c-95fd-794666e79e30", "dosage_form": "KIT", "product_ndc": "61874-170", "generic_name": "cariprazine", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vraylar", "application_number": "NDA204370", "marketing_category": "NDA", "marketing_start_date": "20150917", "listing_expiration_date": "20261231"}