NDC 10129-006

Orostat 8%

Epinephrine Hydrochloride

Orostat 8% is a Dental; Periodontal; Subgingival Solution in the Human Otc Drug category. It is labeled and distributed by Gingi-pak A Division Of The Belport. The primary component is Epinephrine Hydrochloride.

Product ID10129-006_755005b8-165c-b667-e053-2991aa0a3651
NDC10129-006
Product TypeHuman Otc Drug
Proprietary NameOrostat 8%
Generic NameEpinephrine Hydrochloride
Dosage FormSolution
Route of AdministrationDENTAL; PERIODONTAL; SUBGINGIVAL
Marketing Start Date1990-04-04
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameGingi-Pak a Division of the Belport
Substance NameEPINEPHRINE HYDROCHLORIDE
Active Ingredient Strength1200 mg/15mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10129-006-02

15 mL in 1 BOTTLE, GLASS (10129-006-02)
Marketing Start Date1990-04-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10129-006-02 [10129000602]

Orostat 8% SOLUTION
Marketing Categoryunapproved drug other
Product TypeHUMAN OTC DRUG
Marketing Start Date1990-04-04

Drug Details

Active Ingredients

IngredientStrength
EPINEPHRINE HYDROCHLORIDE1200 mg/15mL

OpenFDA Data

SPL SET ID:755005b8-165b-b667-e053-2991aa0a3651
Manufacturer
UNII

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