10129-006 NDC - OROSTAT 8% (EPINEPHRINE HYDROCHLORIDE)

Drug Information

Product NDC: 10129-006

Proprietary Name: Orostat 8%

Non Proprietary Name: EPINEPHRINE HYDROCHLORIDE

Active Ingredient(s):
  • 1200 mg/15mL EPINEPHRINE HYDROCHLORIDE


Administration Route(s): DENTAL; PERIODONTAL; SUBGINGIVAL

Dosage Form(s): SOLUTION

Pharmacy Class(es):
  • Adrenergic alpha-Agonists [MoA];
  • Adrenergic beta-Agonists [MoA];
  • Catecholamine [EPC];
  • Catecholamines [CS];
  • alpha-Adrenergic Agonist [EPC];
  • beta-Adrenergic Agonist [EPC]

Labeler Information

Labeler Name: Gingi-Pak a Division of the Belport
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:4/4/1990

Package Information

No. Package Code Package Description Billing Unit
110129-006-0215 mL in 1 BOTTLE, GLASS (10129-006-02)

NDC Record

Field Name Field Value Definition
PRODUCT NDC10129-006The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEOrostat 8%The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEEPINEPHRINE HYDROCHLORIDEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEDENTAL; PERIODONTAL; SUBGINGIVALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE4/4/1990This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEGingi-Pak a Division of the BelportName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEEPINEPHRINE HYDROCHLORIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH1200 
ACTIVE INGRED UNITmg/15mL 
PHARM CLASSESAdrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC] 

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This page was last updated on: 2/1/2023