Betaloan SUIK
Betaloan Suik Kit
016a47f2-8524-4178-e063-6294a90ab36e
HUMAN PRESCRIPTION DRUG LABEL
Jul 26, 2023
Advanced Rx Pharmacy of Tennessee, LLC
DUNS: 117023142
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Betamethasone Sodium Phosphate and Betamethasone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (7)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel – Carton Label
NDC: 80425-0347-01 Rx Only
Betaloan SUIK
Kit Contains
1 Betamethasone Sodium Phosphate and Betamethasone Acetate mg/mL (5mL)
1 Gebauer's Pain Ease ®(30mL)
1 BD Integra Syringe with Retracting BD PrecisionGlide™ Needle (3mL 23G x 1”)
1 BD Integra Syringe with Retracting BD PrecisionGlide™ Needle (3mL 25G x 1”)
1 Pair Nitrile Powder Free Sterile Gloves (M)
1 Drape
1 Adhesive Bandage
1 Isopropyl Alcohol 70% Prep Pad
5 Non-sterile 4x4 gauze
1 Face Mask
1 Dose
Single Use Only
Distributed by
Advanced Rx Pharmacy of Tennessee, LLC
DESCRIPTION SECTION
DESCRIPTION
Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP is a sterile aqueous suspension containing betamethasone 3 mg per milliliter as betamethasone sodium phosphate, and betamethasone acetate 3 mg per milliliter. Inactive ingredients per mL: dibasic sodium phosphate 7.1 mg; monobasic sodium phosphate 3.4 mg; edetate disodium 0.1 mg; and benzalkonium chloride 0.2 mg as a preservative. The pH is adjusted to between 6.8 and 7.2.
The formula for betamethasone sodium phosphate is C 22H 28FNa 2O 8P and it has a molecular weight of 516.40. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-(disodium phosphate).
The formula for betamethasone acetate is C 24H 31FO 6and it has a molecular weight of 434.50. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-acetate.
The chemical structures for betamethasone sodium phosphate and betamethasone acetate are as follows:
Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic. It is freely soluble in water and in methanol, but is practically insoluble in acetone and in chloroform.
Betamethasone acetate is a white to creamy white, odorless powder that sinters and resolidifies at about 165ºC, and remelts at about 200ºC to 220ºC with decomposition. It is practically insoluble in water, but freely soluble in acetone, and is soluble in alcohol and in chloroform.