JBA Omelia

Product NDC
13411-857
11-digit product format
134110857
Labeler code
13411
Product ID
13411-857_31a6113c-0abc-0412-e063-6394a90ac49a
Type
HUMAN OTC DRUG
Nonproprietary name
Sea Buckthorn extract,Maca (Lepidium meyenii) extract,Tongkat Ali (Eurycoma longifolia) Peptides
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-08-19
Substance
EURYCOMA LONGIFOLIA ROOT; HIPPOPHAE RHAMNOIDES WHOLE; LEPIDIUM MEYENII ROOT
Active strength
20; 380; 120 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
JBA Omelia
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EURYCOMA LONGIFOLIA ROOT20 mg/1
HIPPOPHAE RHAMNOIDES WHOLE380 mg/1
LEPIDIUM MEYENII ROOT120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii43B8E2HG8B, YAA7TG74X6, HP7119212T

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-857-15JBA Omelia15 in 1 BOTTLECAPSULE152
13411-857-30JBA Omelia30 in 1 BOTTLECAPSULE302
13411-857-60JBA Omelia60 in 1 BOTTLECAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-857JBA OMELIA (SEA BUCKTHORN EXTRACT,MACA (LEPIDIUM MEYENII) EXTRACT,TONGKAT ALI (EURYCOMA LONGIFOLIA) PEPTIDES) CAPSULE [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]2Current NDC, 3 package rows20250402_ae63fe31-f602-4171-abed-a7212864d064.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13411-857-151341108571515 CAPSULE in 1 BOTTLE (13411-857-15) 15 capsule2024-08-19NoNoHistorical
13411-857-301341108573030 CAPSULE in 1 BOTTLE (13411-857-30) 30 capsule2024-08-19NoNoHistorical
13411-857-601341108576060 CAPSULE in 1 BOTTLE (13411-857-60) 60 capsule2024-08-19NoNoHistorical