testosterone

Generic: testosterone

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name testosterone
Generic Name testosterone
Labeler actavis pharma, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

testosterone 10 mg/g

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3216
Product ID 0591-3216_38f554a5-ee64-4429-96c5-52b02c7763c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076737
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2015-12-04

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 05913216
Hyphenated Format 0591-3216

Supplemental Identifiers

RxCUI
1596780 1597123 1597129
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 ANDA076737 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (0591-3216-30) / 2.5 g in 1 PACKET (0591-3216-17)
source: ndc

Packages (1)

0591-3216-30 30 PACKET in 1 CARTON (0591-3216-30) / 2.5 g in 1 PACKET (0591-3216-17)

Ingredients (1)

testosterone (10 mg/g)

Linked Drug Pages (1)

Testosterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "38f554a5-ee64-4429-96c5-52b02c7763c1", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "unii": ["3XMK78S47O"], "rxcui": ["1596780", "1597123", "1597129"], "spl_set_id": ["5834d34f-839d-412c-b74c-da1dad2cfa88"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (0591-3216-30)  / 2.5 g in 1 PACKET (0591-3216-17)", "package_ndc": "0591-3216-30", "marketing_start_date": "20151204"}], "brand_name": "Testosterone", "product_id": "0591-3216_38f554a5-ee64-4429-96c5-52b02c7763c1", "dosage_form": "GEL", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "0591-3216", "dea_schedule": "CIII", "generic_name": "Testosterone", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Testosterone", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "10 mg/g"}], "application_number": "ANDA076737", "marketing_category": "ANDA", "marketing_start_date": "20151204", "listing_expiration_date": "20271231"}