octreotide acetate

Generic: octreotide acetate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name octreotide acetate
Generic Name octreotide acetate
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

octreotide acetate 1000 ug/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-516
Product ID 68083-516_5869eaa3-e390-4dff-97df-1adf431ef64f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216807
Listing Expiration 2026-12-31
Marketing Start 2023-06-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083516
Hyphenated Format 68083-516

Supplemental Identifiers

RxCUI
312071 314152
UPC
0368083515010 0368083516017
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 ANDA216807 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1000 ug/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-516-01) / 5 mL in 1 VIAL
source: ndc

Packages (1)

68083-516-01 1 VIAL in 1 CARTON (68083-516-01) / 5 mL in 1 VIAL

Ingredients (1)

octreotide acetate (1000 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": "5869eaa3-e390-4dff-97df-1adf431ef64f", "openfda": {"upc": ["0368083515010", "0368083516017"], "unii": ["75R0U2568I"], "rxcui": ["312071", "314152"], "spl_set_id": ["2344ae7a-c2f0-433b-9133-1dcb16bb18a0"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-516-01)  / 5 mL in 1 VIAL", "package_ndc": "68083-516-01", "marketing_start_date": "20230613"}], "brand_name": "Octreotide Acetate", "product_id": "68083-516_5869eaa3-e390-4dff-97df-1adf431ef64f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "68083-516", "generic_name": "Octreotide Acetate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Octreotide Acetate", "active_ingredients": [{"name": "OCTREOTIDE ACETATE", "strength": "1000 ug/mL"}], "application_number": "ANDA216807", "marketing_category": "ANDA", "marketing_start_date": "20230613", "listing_expiration_date": "20261231"}