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NDC 44117-0002-01 Testosterone 30 [hp_X]/1 Details

Testosterone 30 [hp_X]/1

Testosterone is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Zoe Processing. The primary component is TESTOSTERONE.

Product Information

NDC	44117-0002
Product ID	44117-0002_0d0022f3-9676-4fa7-b349-8d0ce26d1f1f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Testosterone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Testosterone,
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	30
Active Ingredient Units	[hp_X]/1
Substance Name	TESTOSTERONE
Labeler Name	Zoe Processing
Pharmaceutical Class	Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA Schedule	CIII
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 44117-0002-01 (44117000201)

Pricing Information	N/A
NDC Package Code	44117-0002-1
Billing NDC	44117000201
Package	50 TABLET in 1 BOTTLE (44117-0002-1)
Marketing Start Date	2014-04-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 584c2080-1360-40ee-ad54-e13ff5d72be0 Details

ACTIVE INGREDIENT:

Testosterone 30X.

INDICATIONS:

May help increase lean muscle mass and sexual libido, also may help decrease symptoms of fatigue.

WARNINGS:

Not intended for persons under the age of 18.

If pregnant or breast-feeding, do not use.

Consult a health professional prior to use if you have any pre-existing medical conditions or take any prescription medications.

Do not consume with any caffeine or stimulants. Improper use will not improve results and is potentially hazardous to a person's health.

Use only as directed.

Keep out of reach of children. In case of overdose, get medical help or contact a Poision Control Center right away.

Do not use if tamper evident seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Adults take 1-2 tablets daily. Read warnings and use only as directed.

INDICATIONS:

May help increase lean muscle mass and sexual libido, also may help decrease symptoms of fatigue.

INACTIVE INGREDIENTS:

Microcrystaline cellulose, Magnesium stearate, Croscarmellose sodium, Silicon dioxide, Stearic acid.

QUESTIONS:

Developed and manufactured for:

Zoe Processing

P.O. Box 487

Avon, OH 44011

WWW.TESTOSTERONERX.COM

To report a serious adverse event or obtain product information, please cal 1-866-607-2768.

PACKAGE LABEL DISPLAY:

Testosterone Tablets

Homeopathic

50 tablets

INGREDIENTS AND APPEARANCE

TESTOSTERONE

testosterone, tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44117-0002
Route of Administration	ORAL	DEA Schedule	CIII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)	TESTOSTERONE	30 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
CREATINE MONOHYDRATE (UNII: 9603LN7R2Q)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	capsule (LARGE CAPLET TABLET)	Size	22mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:44117-0002-1	50 in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/29/2014

Labeler - Zoe Processing (040866348)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(44117-0002) , api manufacture(44117-0002) , label(44117-0002) , pack(44117-0002)

Revised: 11/2019

Document Id: 0d0022f3-9676-4fa7-b349-8d0ce26d1f1f

Set id: 584c2080-1360-40ee-ad54-e13ff5d72be0

Version: 2

Effective Time: 20191111

Search by Drug Name or NDC

NDC 44117-0002-01 Testosterone 30 [hp_X]/1 Details

Testosterone 30 [hp_X]/1

Product Information

Package

Package Images

NDC 44117-0002-01 (44117000201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 584c2080-1360-40ee-ad54-e13ff5d72be0 Details

ACTIVE INGREDIENT:

INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN:

DIRECTIONS:

INDICATIONS:

INACTIVE INGREDIENTS:

QUESTIONS:

PACKAGE LABEL DISPLAY:

INGREDIENTS AND APPEARANCE

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