octreotide acetate

Generic: octreotide acetate

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

Drug Facts

Product Profile

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

octreotide acetate 500 ug/mL

Manufacturer
GLENMARK PHARMACEUTICALS INC., USA

Identifiers & Regulatory

Product NDC 68462-897
Product ID 68462-897_1a5d8576-7695-42f0-871a-d8de8c7b0220
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216839
Listing Expiration 2027-12-31
Marketing Start 2023-08-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462897
Hyphenated Format 68462-897

Supplemental Identifiers

RxCUI
312069 312070
UPC
0368462897102 0368462896105
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 ANDA216839 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 500 ug/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68462-897-10) / 1 mL in 1 VIAL (68462-897-01)
source: ndc

Packages (1)

68462-897-10 10 VIAL in 1 CARTON (68462-897-10) / 1 mL in 1 VIAL (68462-897-01)

Ingredients (1)

octreotide acetate (500 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": "1a5d8576-7695-42f0-871a-d8de8c7b0220", "openfda": {"upc": ["0368462897102", "0368462896105"], "unii": ["75R0U2568I"], "rxcui": ["312069", "312070"], "spl_set_id": ["387d7f8d-9762-4f6b-99e1-bdc50b8a1633"], "manufacturer_name": ["GLENMARK PHARMACEUTICALS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68462-897-10)  / 1 mL in 1 VIAL (68462-897-01)", "package_ndc": "68462-897-10", "marketing_start_date": "20230809"}], "brand_name": "Octreotide Acetate", "product_id": "68462-897_1a5d8576-7695-42f0-871a-d8de8c7b0220", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "68462-897", "generic_name": "Octreotide Acetate", "labeler_name": "GLENMARK PHARMACEUTICALS INC., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Octreotide Acetate", "active_ingredients": [{"name": "OCTREOTIDE ACETATE", "strength": "500 ug/mL"}], "application_number": "ANDA216839", "marketing_category": "ANDA", "marketing_start_date": "20230809", "listing_expiration_date": "20271231"}