risperidone

Generic: risperidone

Labeler: atlantic biologicals corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler atlantic biologicals corp.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

risperidone 1 mg/mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-1002
Product ID 17856-1002_38521896-8588-7eb4-e063-6294a90a1fb0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079059
Listing Expiration 2026-12-31
Marketing Start 2015-03-13

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178561002
Hyphenated Format 17856-1002

Supplemental Identifiers

RxCUI
199387
UNII
L6UH7ZF8HC
NUI
N0000175430

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 risperidone (source: ndc)
Generic Name risperidone (source: ndc)
Application Number ANDA079059 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1002-1) / 1 mL in 1 SYRINGE
  • 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1002-2) / 1 mL in 1 SYRINGE
  • 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1002-3) / 2 mL in 1 SYRINGE
source: ndc

Packages (3)

17856-1002-1 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1002-1) / 1 mL in 1 SYRINGE 17856-1002-2 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1002-2) / 1 mL in 1 SYRINGE 17856-1002-3 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1002-3) / 2 mL in 1 SYRINGE

Ingredients (1)

risperidone (1 mg/mL)

Linked Drug Pages (1)

Risperidone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "38521896-8588-7eb4-e063-6294a90a1fb0", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["199387"], "spl_set_id": ["dc8c6638-f487-49df-a265-78caa93e43d8"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1002-1)  / 1 mL in 1 SYRINGE", "package_ndc": "17856-1002-1", "marketing_start_date": "20240919"}, {"sample": false, "description": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1002-2)  / 1 mL in 1 SYRINGE", "package_ndc": "17856-1002-2", "marketing_start_date": "20240919"}, {"sample": false, "description": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1002-3)  / 2 mL in 1 SYRINGE", "package_ndc": "17856-1002-3", "marketing_start_date": "20240919"}], "brand_name": "Risperidone", "product_id": "17856-1002_38521896-8588-7eb4-e063-6294a90a1fb0", "dosage_form": "SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "17856-1002", "generic_name": "Risperidone", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "1 mg/mL"}], "application_number": "ANDA079059", "marketing_category": "ANDA", "marketing_start_date": "20150313", "listing_expiration_date": "20261231"}