Prodigen Capsules Dietary Supplement

Manufacturer
Sterling Knight Pharmaceuticals LLC
Effective date
2018-07-31
Label type
DIETARY SUPPLEMENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:49:03

Label at a glance#

ProductProdigen
Active ingredientLACTOBACILLUS ACIDOPHILUS, BIFIDOBACTERIUM ANIMALIS LACTIS
Label structure7 sections

Dosage and administration

Usual adult dose is 1 capsule daily with or without food. INDICATIONS AND USAGE Prodigen is an orally administered prescription probiotic formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

Label contents#

Full prescribing information#

HEALTH CLAIM:

HEALTH CLAIM SECTION

Prodigen Capsules Dietary Supplemement

Dispensed by Prescription†

suppfactssuppfacts

DESCRIPTION

STATEMENT OF IDENTITY SECTION

Prodigen is an orally administered prescription probiotic formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

Prodigen should be administered under the supervision of a licensed medical practitioner.

WARNINGS AND PRECAUTIONS

WARNINGS SECTION

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Prodigen should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

DOSAGE AND ADMINISTRATION

SAFE HANDLING WARNING SECTION

Usual adult dose is 1 capsule daily with or without food.

INDICATIONS AND USAGE

Prodigen is an orally administered prescription probiotic formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

HOW SUPPLIED:

PRECAUTIONS SECTION

Prodigen is supplied as clear capsules dispensed in HDPE plastic bottles of 30ct.

69336-402-30

Reserved for Professional Recommendation
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.
Manufactured for:
Sterling-Knight Pharmaceuticals, LLC
Ripley, MS 38663

Item 40230
Rev. 0418-1

STORAGE:

SAFE HANDLING WARNING SECTION

Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

KEEP THIS OUT OF THE REACH OF CHILDREN.

PACKAGE LABEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

prodlabelprodlabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2043695Lactobacillus acidophilus 16 Billion UNT / Bifidobacterium animalis 15 Billion UNT Oral CapsulePSN2
2043695Bifidobacterium animalis 15000000000 UNT / Lactobacillus acidophilus 16000000000 UNT Oral CapsuleSCD2
2043695Bifidobacterium animalis 15,000,000,000 UNT / Lactobacillus acidophilus 16,000,000,000 UNT Oral CapsuleSY2
2043695Bifidobacterium animalis lactis 15,000,000,000 UNT / Lactobacillus acidophilus 16,000,000,000 UNT Oral CapsuleSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369336402309GTIN-13: 0369336402309
EAN-13: 0369336402309
GTIN-12: 369336402309
UPC-A: 369336402309
GTIN storage (14 digits): 00369336402309
prodigenlab.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69336-402-30Prodigen30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69336-402PRODIGEN (LACTOBACILLUS ACIDOPHILUS) CAPSULE [STERLING KNIGHT PHARMACEUTICALS LLC]21 package rows20180731_cfe35d19-52f9-41b7-9997-34bf95c1a898.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69336-40269336-402-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML · Source PDF

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.