octreotide acetate

Generic: octreotide acetate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name octreotide acetate
Generic Name octreotide acetate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

octreotide acetate 100 ug/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6175
Product ID 0641-6175_efa5d8e8-57ab-4b56-b8d7-f856ea97404c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076313
Listing Expiration 2027-12-31
Marketing Start 2005-04-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416175
Hyphenated Format 0641-6175

Supplemental Identifiers

RxCUI
312068 312069 312070 312071 314152
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 ANDA076313 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6175-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6175-01)
source: ndc

Packages (1)

0641-6175-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6175-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6175-01)

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": "efa5d8e8-57ab-4b56-b8d7-f856ea97404c", "openfda": {"unii": ["75R0U2568I"], "rxcui": ["312068", "312069", "312070", "312071", "314152"], "spl_set_id": ["9502860d-0261-4d69-a4be-827a5376d356"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6175-10)  / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6175-01)", "package_ndc": "0641-6175-10", "marketing_start_date": "20050404"}], "brand_name": "Octreotide Acetate", "product_id": "0641-6175_efa5d8e8-57ab-4b56-b8d7-f856ea97404c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "0641-6175", "generic_name": "Octreotide Acetate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Octreotide Acetate", "active_ingredients": [{"name": "OCTREOTIDE ACETATE", "strength": "100 ug/mL"}], "application_number": "ANDA076313", "marketing_category": "ANDA", "marketing_start_date": "20050404", "listing_expiration_date": "20271231"}