aripiprazole

Generic: aripiprazole

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aripiprazole
Generic Name aripiprazole
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

aripiprazole 20 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-434
Product ID 67877-434_583fc581-09d7-4d4f-a079-08ba9d00f775
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207105
Listing Expiration 2026-12-31
Marketing Start 2019-02-27

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877434
Hyphenated Format 67877-434

Supplemental Identifiers

RxCUI
349490 349545 349547 349553 402131 602964
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 ANDA207105 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (67877-434-01)
  • 30 TABLET in 1 BOTTLE (67877-434-03)
  • 500 TABLET in 1 BOTTLE (67877-434-05)
  • 10 BLISTER PACK in 1 CARTON (67877-434-38) / 10 TABLET in 1 BLISTER PACK (67877-434-33)
source: ndc

Packages (4)

67877-434-01 100 TABLET in 1 BOTTLE (67877-434-01) 67877-434-03 30 TABLET in 1 BOTTLE (67877-434-03) 67877-434-05 500 TABLET in 1 BOTTLE (67877-434-05) 67877-434-38 10 BLISTER PACK in 1 CARTON (67877-434-38) / 10 TABLET in 1 BLISTER PACK (67877-434-33)

Ingredients (1)

aripiprazole (20 mg/1)

Linked Drug Pages (1)

Aripiprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "583fc581-09d7-4d4f-a079-08ba9d00f775", "openfda": {"nui": ["N0000175430"], "unii": ["82VFR53I78"], "rxcui": ["349490", "349545", "349547", "349553", "402131", "602964"], "spl_set_id": ["c7040fef-96a7-4429-9a8e-ec3ab17a8019"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (67877-434-01)", "package_ndc": "67877-434-01", "marketing_start_date": "20190227"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (67877-434-03)", "package_ndc": "67877-434-03", "marketing_start_date": "20190227"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (67877-434-05)", "package_ndc": "67877-434-05", "marketing_start_date": "20190227"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-434-38)  / 10 TABLET in 1 BLISTER PACK (67877-434-33)", "package_ndc": "67877-434-38", "marketing_start_date": "20190227"}], "brand_name": "Aripiprazole", "product_id": "67877-434_583fc581-09d7-4d4f-a079-08ba9d00f775", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "67877-434", "generic_name": "Aripiprazole", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aripiprazole", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA207105", "marketing_category": "ANDA", "marketing_start_date": "20190227", "listing_expiration_date": "20261231"}