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NDC 10129-0031-01 STASIS 3150 mg/15mL Details

STASIS 3150 mg/15mL

STASIS 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 FERRIC SULFATE.

Product Information

NDC	10129-0031
Product ID	10129-031_e41c0322-5721-3107-e053-2995a90aff8e
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	STASIS
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ferric Sulfate
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	DENTAL; PERIODONTAL; SUBGINGIVAL
Active Ingredient Strength	3150
Active Ingredient Units	mg/15mL
Substance Name	FERRIC SULFATE
Labeler Name	Gingi-Pak a Division of the Belport
Pharmaceutical Class	Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10129-0031-01 (10129003101)

Pricing Information	N/A
NDC Package Code	10129-031-01
Billing NDC	10129003101
Package	15 mL in 1 BOTTLE, GLASS (10129-031-01)
Marketing Start Date	1987-06-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 758b87c1-886f-4316-e053-2a91aa0ac7be Details

Active Ingredient

Purpose

Uses

Directions

Warning

Keep out of reach of children

Stop use and ask a doctor

Precautions

Storage

Inactive ingredient

Principal Display-Stasis 15 cc

Principal Display-Stasis 40 cc

INGREDIENTS AND APPEARANCE

STASIS

ferric sulfate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-031
Route of Administration	DENTAL, PERIODONTAL, SUBGINGIVAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FERRIC SULFATE (UNII: 3HWS7HF5XD) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	3150 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	0.45 mL in 15 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10129-031-01	15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/26/1987
2	NDC:10129-031-02	40 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/26/1987

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/26/1987

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(10129-031)

Revised: 7/2022

Document Id: e41c0322-5721-3107-e053-2995a90aff8e

Set id: 758b87c1-886f-4316-e053-2a91aa0ac7be

Version: 2

Effective Time: 20220718