testosterone

Generic: testosterone

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

Drug Facts

Product Profile

Brand Name testosterone
Generic Name testosterone
Labeler strides pharma science limited
Dosage Form GEL
Routes
TRANSDERMAL
Active Ingredients

testosterone 50 mg/5g

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-152
Product ID 64380-152_6d50f17e-4607-458a-882b-620daa3b58a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076744
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2022-06-27

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 64380152
Hyphenated Format 64380-152

Supplemental Identifiers

RxCUI
1597123 1597129
UPC
0364380151012 0364380152019
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 ANDA076744 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5g
source: ndc
Packaging
  • 30 DOSE PACK in 1 CARTON (64380-152-02) / 5 g in 1 DOSE PACK (64380-152-01)
source: ndc

Packages (1)

64380-152-02 30 DOSE PACK in 1 CARTON (64380-152-02) / 5 g in 1 DOSE PACK (64380-152-01)

Ingredients (1)

testosterone (50 mg/5g)

Linked Drug Pages (1)

Testosterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "6d50f17e-4607-458a-882b-620daa3b58a9", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "upc": ["0364380151012", "0364380152019"], "unii": ["3XMK78S47O"], "rxcui": ["1597123", "1597129"], "spl_set_id": ["ee54c393-bcfe-4a52-b7b3-1da8750f35d9"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 DOSE PACK in 1 CARTON (64380-152-02)  / 5 g in 1 DOSE PACK (64380-152-01)", "package_ndc": "64380-152-02", "marketing_start_date": "20220627"}], "brand_name": "Testosterone", "product_id": "64380-152_6d50f17e-4607-458a-882b-620daa3b58a9", "dosage_form": "GEL", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "64380-152", "dea_schedule": "CIII", "generic_name": "Testosterone", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Testosterone", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "50 mg/5g"}], "application_number": "ANDA076744", "marketing_category": "ANDA", "marketing_start_date": "20220627", "listing_expiration_date": "20261231"}