paricalcitol

Generic: paricalcitol

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paricalcitol
Generic Name paricalcitol
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

paricalcitol 1 ug/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-822
Product ID 65162-822_35e96bd0-ee09-4adc-a04d-7dcd43466786
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204327
Listing Expiration 2026-12-31
Marketing Start 2016-01-15

Pharmacologic Class

Established (EPC)
vitamin d2 analog [epc] vitamin d analog [epc]
Chemical Structure
ergocalciferols [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162822
Hyphenated Format 65162-822

Supplemental Identifiers

RxCUI
577315 577317 577324
UPC
0365162822090 0365162823097 0365162824094
UNII
6702D36OG5
NUI
M0007651 N0000175907 N0000175849

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 paricalcitol (source: ndc)
Generic Name paricalcitol (source: ndc)
Application Number ANDA204327 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 ug/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (65162-822-03)
  • 90 CAPSULE in 1 BOTTLE (65162-822-09)
source: ndc

Packages (2)

65162-822-03 30 CAPSULE in 1 BOTTLE (65162-822-03) 65162-822-09 90 CAPSULE in 1 BOTTLE (65162-822-09)

Ingredients (1)

paricalcitol (1 ug/1)

Linked Drug Pages (1)

Paricalcitol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "35e96bd0-ee09-4adc-a04d-7dcd43466786", "openfda": {"nui": ["M0007651", "N0000175907", "N0000175849"], "upc": ["0365162822090", "0365162823097", "0365162824094"], "unii": ["6702D36OG5"], "rxcui": ["577315", "577317", "577324"], "spl_set_id": ["cd937aab-6ed2-44ef-b91e-82738997ed10"], "pharm_class_cs": ["Ergocalciferols [CS]"], "pharm_class_epc": ["Vitamin D2 Analog [EPC]", "Vitamin D Analog [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (65162-822-03)", "package_ndc": "65162-822-03", "marketing_start_date": "20160115"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (65162-822-09)", "package_ndc": "65162-822-09", "marketing_start_date": "20160115"}], "brand_name": "Paricalcitol", "product_id": "65162-822_35e96bd0-ee09-4adc-a04d-7dcd43466786", "dosage_form": "CAPSULE", "pharm_class": ["Ergocalciferols [CS]", "Vitamin D Analog [EPC]", "Vitamin D2 Analog [EPC]"], "product_ndc": "65162-822", "generic_name": "Paricalcitol", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paricalcitol", "active_ingredients": [{"name": "PARICALCITOL", "strength": "1 ug/1"}], "application_number": "ANDA204327", "marketing_category": "ANDA", "marketing_start_date": "20160115", "listing_expiration_date": "20261231"}