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NDC 10129-0006-02 Orostat 8% 1200 mg/15mL Details

Orostat 8% 1200 mg/15mL

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 Information

NDC	10129-0006
Product ID	10129-006_755005b8-165c-b667-e053-2991aa0a3651
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	Orostat 8%
Proprietary Name Suffix	n/a
Non-Proprietary Name	EPINEPHRINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	DENTAL; PERIODONTAL; SUBGINGIVAL
Active Ingredient Strength	1200
Active Ingredient Units	mg/15mL
Substance Name	EPINEPHRINE HYDROCHLORIDE
Labeler Name	Gingi-Pak a Division of the Belport
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10129-0006-02 (10129000602)

Pricing Information	N/A
NDC Package Code	10129-006-02
Billing NDC	10129000602
Package	15 mL in 1 BOTTLE, GLASS (10129-006-02)
Marketing Start Date	1990-04-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 755005b8-165b-b667-e053-2991aa0a3651 Details

Active Ingredient

Purpose

Description

Inactive Ingredient

Keep out of reach if children

Storage

Uses

Do not use

Warnings

Directions

Principal Display-Orostat 8%

INGREDIENTS AND APPEARANCE

OROSTAT 8%

epinephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-006
Route of Administration	SUBGINGIVAL, PERIODONTAL, DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE HYDROCHLORIDE	1200 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM DITHIONITE (UNII: 2K5B8F6ES1)	37.5 mg in 15 mL
SODIUM THIOSULFATE (UNII: HX1032V43M)	15 mg in 15 mL
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)	37.5 mg in 15 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	49.5 mg in 15 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	4.95 mg in 15 mL
BENZYL ALCOHOL (UNII: LKG8494WBH)	0.15 mL in 15 mL
EDETIC ACID (UNII: 9G34HU7RV0)	1.995 mg in 15 mL
METHYLPARABEN (UNII: A2I8C7HI9T)	10.05 mg in 15 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-006-02	15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/04/1990

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/04/1990

Labeler - Gingi-Pak a Division of the Belport (008480121)

Registrant - Jeff Nichols (008480121)

Name	Address	ID/FEI	Business Operations
Establishment
Gingi-Pak a Division of the Belport		008480121	manufacture(10129-006)

Revised: 1/2018

Document Id: 755005b8-165c-b667-e053-2991aa0a3651

Set id: 755005b8-165b-b667-e053-2991aa0a3651

Version: 1

Effective Time: 20180111