azmiro

Generic: testosterone cypionate

Labeler: azurity pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name azmiro
Generic Name testosterone cypionate
Labeler azurity pharmaceuticals, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

testosterone cypionate 200 mg/mL

Manufacturer
Azurity Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 24338-055
Product ID 24338-055_5cf15fb2-1ba1-4295-9ddf-e98434ccd1c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216318
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2024-10-04

Pharmacologic Class

Classes
androgen receptor agonists [moa] androgen [epc] androstanes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24338055
Hyphenated Format 24338-055

Supplemental Identifiers

RxCUI
2047882 2694309 2694316 2694320
UPC
0324338055014
UNII
M0XW1UBI14

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 azmiro (source: ndc)
Generic Name testosterone cypionate (source: ndc)
Application Number NDA216318 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (24338-055-01) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

24338-055-01 1 SYRINGE, GLASS in 1 CARTON (24338-055-01) / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

testosterone cypionate (200 mg/mL)

Linked Drug Pages (1)

AZMIRO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "5cf15fb2-1ba1-4295-9ddf-e98434ccd1c2", "openfda": {"upc": ["0324338055014"], "unii": ["M0XW1UBI14"], "rxcui": ["2047882", "2694309", "2694316", "2694320"], "spl_set_id": ["235b5625-570d-3fba-e063-6394a90aa2d1"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (24338-055-01)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "24338-055-01", "marketing_start_date": "20241004"}], "brand_name": "AZMIRO", "product_id": "24338-055_5cf15fb2-1ba1-4295-9ddf-e98434ccd1c2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "24338-055", "dea_schedule": "CIII", "generic_name": "TESTOSTERONE CYPIONATE", "labeler_name": "Azurity Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZMIRO", "active_ingredients": [{"name": "TESTOSTERONE CYPIONATE", "strength": "200 mg/mL"}], "application_number": "NDA216318", "marketing_category": "NDA", "marketing_start_date": "20241004", "listing_expiration_date": "20261231"}