octreotide acetate

Generic: octreotide acetate

Labeler: hainan shuangcheng pharmaceuticals co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name octreotide acetate
Generic Name octreotide acetate
Labeler hainan shuangcheng pharmaceuticals co., ltd.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

octreotide acetate 100 ug/mL

Manufacturer
Hainan Shuangcheng Pharmaceuticals Co., Ltd.

Identifiers & Regulatory

Product NDC 52958-046
Product ID 52958-046_dc2c72fd-ddb4-4933-8ef2-1edfbe7740f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217860
Listing Expiration 2026-12-31
Marketing Start 2024-05-02

Pharmacologic Class

Classes
somatostatin analog [epc] somatostatin receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52958046
Hyphenated Format 52958-046

Supplemental Identifiers

RxCUI
312069
UNII
75R0U2568I

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 octreotide acetate (source: ndc)
Generic Name octreotide acetate (source: ndc)
Application Number ANDA217860 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (52958-046-10) / 1 mL in 1 VIAL, GLASS (52958-046-01)
source: ndc

Packages (1)

52958-046-10 10 VIAL, GLASS in 1 CARTON (52958-046-10) / 1 mL in 1 VIAL, GLASS (52958-046-01)

Ingredients (1)

octreotide acetate (100 ug/mL)

Linked Drug Pages (1)

OCTREOTIDE ACETATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "dc2c72fd-ddb4-4933-8ef2-1edfbe7740f2", "openfda": {"unii": ["75R0U2568I"], "rxcui": ["312069"], "spl_set_id": ["ab9b0d3d-4dab-4c5b-9c23-3a14f8fcfcde"], "manufacturer_name": ["Hainan Shuangcheng Pharmaceuticals Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (52958-046-10)  / 1 mL in 1 VIAL, GLASS (52958-046-01)", "package_ndc": "52958-046-10", "marketing_start_date": "20240502"}], "brand_name": "OCTREOTIDE ACETATE", "product_id": "52958-046_dc2c72fd-ddb4-4933-8ef2-1edfbe7740f2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "52958-046", "generic_name": "octreotide acetate", "labeler_name": "Hainan Shuangcheng Pharmaceuticals Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OCTREOTIDE ACETATE", "active_ingredients": [{"name": "OCTREOTIDE ACETATE", "strength": "100 ug/mL"}], "application_number": "ANDA217860", "marketing_category": "ANDA", "marketing_start_date": "20240502", "listing_expiration_date": "20261231"}