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
IngredientStrength
BETAMETHASONE ACETATE3 mg/mL
BETAMETHASONE SODIUM PHOSPHATE3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTI05AO53L7, 7BK02SCL3W

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0347-1Betaloan SUIK5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION52
80425-0347-1Betaloan SUIK1 in 1 CARTONINJECTION, SUSPENSION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0347-1EA - Each80425-034776c77867-c45e-4710-83f2-4335e670591a12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0347BETALOAN SUIK (BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE) INJECTION, SUSPENSION [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 2 package rows20250102_016a47f2-8524-4178-e063-6294a90ab36e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0347-1804250347011 VIAL, MULTI-DOSE in 1 CARTON (80425-0347-1) / 5 mL in 1 VIAL, MULTI-DOSE2023-07-26NoNoHistorical