testosterone

Generic: testosterone

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

Drug Facts

Product Profile

Brand Name testosterone
Generic Name testosterone
Labeler cipla usa inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

testosterone 30 mg/1.5mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-363
Product ID 69097-363_ce2732a6-d90e-442c-b7d0-dc1d65a7e3cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209533
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2018-03-30

Pharmacologic Class

Established (EPC)
androgen [epc]
Mechanism of Action
androgen receptor agonists [moa]
Chemical Structure
androstanes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097363
Hyphenated Format 69097-363

Supplemental Identifiers

RxCUI
1599949
UNII
3XMK78S47O
NUI
N0000175824 N0000000146 M0001109

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 (source: ndc)
Generic Name testosterone (source: ndc)
Application Number ANDA209533 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1.5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69097-363-44) / 90 mL in 1 BOTTLE
source: ndc

Packages (1)

69097-363-44 1 BOTTLE in 1 CARTON (69097-363-44) / 90 mL in 1 BOTTLE

Ingredients (1)

testosterone (30 mg/1.5mL)

Linked Drug Pages (1)

Testosterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ce2732a6-d90e-442c-b7d0-dc1d65a7e3cc", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "unii": ["3XMK78S47O"], "rxcui": ["1599949"], "spl_set_id": ["6a46b5de-5d95-4570-91a6-3e4278028c59"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69097-363-44)  / 90 mL in 1 BOTTLE", "package_ndc": "69097-363-44", "marketing_start_date": "20180330"}], "brand_name": "Testosterone", "product_id": "69097-363_ce2732a6-d90e-442c-b7d0-dc1d65a7e3cc", "dosage_form": "SOLUTION", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "69097-363", "dea_schedule": "CIII", "generic_name": "Testosterone", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Testosterone", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "30 mg/1.5mL"}], "application_number": "ANDA209533", "marketing_category": "ANDA", "marketing_start_date": "20180330", "listing_expiration_date": "20261231"}