Probinate
- Manufacturer
- PureTek Corporation
- Effective date
- 2021-08-17
- Label type
- DIETARY SUPPLEMENT
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:50:06
Label at a glance#
ProductProbinate
Active ingredientLACTOBACILLUS ACIDOPHILUS, BIFIDOBACTERIUM ANIMALIS LACTIS
Label structure6 sections
Contacts and useful links#
Label contents#
Full prescribing information#
STATEMENT OF IDENTITY
Probinate™
Other Ingredients: Potato Starch, Magnesium Stearate,Ascorbic Acid, Vegetable Capsule (Hydroxypropylmethylcellulose).
Probinate™ 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.
Probinate™ should be administered under the supervision of a licensed medical practitioner.
Probinate™ is manufactured in accordance with Current Good Manufacturing Practice for foods, using ingredients that have been approved by the U.S. Food and Drug Administration (FDA) as food additives or are Generally Recognized as Safe (GRAS) for their intended use.
DOSAGE
Usual Adult dose is one capsule once daily, or as prescribed by a licensed medical practitioner.
If you are pregnant or nursing, ask a healthcare professional.
Probinate™ should be administered under the supervision of a licensed medical practitioner.
SAFE HANDLING
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Probinate™ 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.
KEEP OUT OF REACH OF CHILDREN
STORAGE
Store at 20° to 25°C (68° to 77°F).
Keep in a cool dry place.
HOW SUPPLIED HEALTH CLAIM
Probinate™, Probiotic
Dietary Supplement
NHRIC: 59088-194-54 *
Bottles contain 30 Capsules
Manufactured in Canada and
Distributed in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free:
1-877-921-7873
*Does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.
† The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product by prescription. This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.
Probinate™
List No: 19454IAA Rev: 38337
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2043695 | Lactobacillus acidophilus 16 Billion UNT / Bifidobacterium animalis 15 Billion UNT Oral Capsule | PSN | 1 |
| 2043695 | Bifidobacterium animalis 15000000000 UNT / Lactobacillus acidophilus 16000000000 UNT Oral Capsule | SCD | 1 |
| 2043695 | Bifidobacterium animalis 15,000,000,000 UNT / Lactobacillus acidophilus 16,000,000,000 UNT Oral Capsule | SY | 1 |
| 2043695 | Bifidobacterium animalis lactis 15,000,000,000 UNT / Lactobacillus acidophilus 16,000,000,000 UNT Oral Capsule | SY | 1 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59088-194-54 | Probinate | 30 in 1 BOTTLE | CAPSULE | 30 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59088-194-54 | EA - Each | 59088-194 | 03e601d7-0677-4e41-af1b-c83647aa636b | 1 | 2021-09-07 |
Products#
Every source-derived product name is available through these pages.
- Probinate
- Probiotic
- LACTOBACILLUS ACIDOPHILUS
- BIFIDOBACTERIUM ANIMALIS LACTIS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59088-194 | 59088-194-54 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LACTOBACILLUS ACIDOPHILUS | 1PRR1V42V5 | ACTIB |
| BIFIDOBACTERIUM ANIMALIS LACTIS | 5307V7XW8I | ACTIB |
Source Document#
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.