testosterone cypionate

Generic: testosterone cypionate

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

Drug Facts

Product Profile

Brand Name testosterone cypionate
Generic Name testosterone cypionate
Labeler cipla usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

testosterone cypionate 200 mg/mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-537
Product ID 69097-537_0fb2cc28-39a1-4a94-a01d-23209732dfd7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210362
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2023-09-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097537
Hyphenated Format 69097-537

Supplemental Identifiers

RxCUI
835829 835840 2047882
UPC
0369097536374 0369097537371 0369097537319
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 testosterone cypionate (source: ndc)
Generic Name testosterone cypionate (source: ndc)
Application Number ANDA210362 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL, GLASS (69097-537-31)
  • 10 mL in 1 VIAL, GLASS (69097-537-37)
source: ndc

Packages (2)

69097-537-31 1 mL in 1 VIAL, GLASS (69097-537-31) 69097-537-37 10 mL in 1 VIAL, GLASS (69097-537-37)

Ingredients (1)

testosterone cypionate (200 mg/mL)

Linked Drug Pages (1)

TESTOSTERONE CYPIONATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "0fb2cc28-39a1-4a94-a01d-23209732dfd7", "openfda": {"upc": ["0369097536374", "0369097537371", "0369097537319"], "unii": ["M0XW1UBI14"], "rxcui": ["835829", "835840", "2047882"], "spl_set_id": ["78d55bad-4a5b-4e21-aeb8-a4c6346208be"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, GLASS (69097-537-31)", "package_ndc": "69097-537-31", "marketing_start_date": "20230915"}, {"sample": false, "description": "10 mL in 1 VIAL, GLASS (69097-537-37)", "package_ndc": "69097-537-37", "marketing_start_date": "20230915"}], "brand_name": "TESTOSTERONE CYPIONATE", "product_id": "69097-537_0fb2cc28-39a1-4a94-a01d-23209732dfd7", "dosage_form": "INJECTION", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "69097-537", "dea_schedule": "CIII", "generic_name": "testosterone cypionate", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TESTOSTERONE CYPIONATE", "active_ingredients": [{"name": "TESTOSTERONE CYPIONATE", "strength": "200 mg/mL"}], "application_number": "ANDA210362", "marketing_category": "ANDA", "marketing_start_date": "20230915", "listing_expiration_date": "20261231"}