Home NDC 80425-0347 Betaloan SUIK
Product NDC 80425-0347
11-digit product format 804250347
Labeler code 80425
Product ID 80425-0347_2a9c3847-6363-8f9e-e063-6394a90a15c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betamethasone Sodium Phosphate and Betamethasone Acetate
Dosage form INJECTION, SUSPENSION
Route INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2023-07-26
Substance BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Active strength 3; 3 mg/mL; mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Betaloan SUIK
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETAMETHASONE SODIUM PHOSPHATE 3 mg/mL BETAMETHASONE ACETATE 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7BK02SCL3W Internal UNII lookup TI05AO53L7 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80425-0347-1 Betaloan SUIK 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SUSPENSION 5 2 80425-0347-1 Betaloan SUIK 1 in 1 CARTON INJECTION, SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0347 BETALOAN SUIK (BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE) INJECTION, SUSPENSION [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 2 Current NDC, 2 package rows 20250102_016a47f2-8524-4178-e063-6294a90ab36e.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Betaloan SUIK BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE Advanced Rx Pharmacy of Tennessee, LLC 016a47f2-8524-4178-e063-6294a90ab36e 2024-12-31 Warnings, Adverse reactions Exact identifier ndc (product): 80425-0347
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 80425-0347-1 80425034701 1 VIAL, MULTI-DOSE in 1 CARTON (80425-0347-1) / 5 mL in 1 VIAL, MULTI-DOSE 2023-07-26 No No Current