aripiprazole

Generic: aripiprazole

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aripiprazole
Generic Name aripiprazole
Labeler lannett company, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

aripiprazole 1 mg/mL

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 54838-570
Product ID 54838-570_de0ee6f0-d4d7-4d86-9ff9-3ee2c687fccc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204171
Listing Expiration 2026-12-31
Marketing Start 2015-08-17

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54838570
Hyphenated Format 54838-570

Supplemental Identifiers

RxCUI
485496
UPC
0354838570595
UNII
82VFR53I78
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 aripiprazole (source: ndc)
Generic Name aripiprazole (source: ndc)
Application Number ANDA204171 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 150 mL in 1 BOTTLE, PLASTIC (54838-570-59)
  • 237 mL in 1 BOTTLE, PLASTIC (54838-570-70)
source: ndc

Packages (2)

54838-570-59 150 mL in 1 BOTTLE, PLASTIC (54838-570-59) 54838-570-70 237 mL in 1 BOTTLE, PLASTIC (54838-570-70)

Ingredients (1)

aripiprazole (1 mg/mL)

Linked Drug Pages (1)

Aripiprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "de0ee6f0-d4d7-4d86-9ff9-3ee2c687fccc", "openfda": {"nui": ["N0000175430"], "upc": ["0354838570595"], "unii": ["82VFR53I78"], "rxcui": ["485496"], "spl_set_id": ["e7292c4c-e332-4ed4-9086-f130d223b6ae"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 mL in 1 BOTTLE, PLASTIC (54838-570-59)", "package_ndc": "54838-570-59", "marketing_start_date": "20150817"}, {"sample": false, "description": "237 mL in 1 BOTTLE, PLASTIC (54838-570-70)", "package_ndc": "54838-570-70", "marketing_start_date": "20150817"}], "brand_name": "Aripiprazole", "product_id": "54838-570_de0ee6f0-d4d7-4d86-9ff9-3ee2c687fccc", "dosage_form": "SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "54838-570", "generic_name": "Aripiprazole", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aripiprazole", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "1 mg/mL"}], "application_number": "ANDA204171", "marketing_category": "ANDA", "marketing_start_date": "20150817", "listing_expiration_date": "20261231"}