Diatrol

Product NDC
59088-162
11-digit product format
590880162
Labeler code
59088
Product ID
59088-162_5a0fe8c6-c758-749c-e063-6294a90a8fd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vitamins and mineral
Dosage form
TABLET
Route
ORAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-01-26
Substance
BIOTIN; VANADYL SULFATE; CHROMIUM NICOTINATE; GYMNEMA SYLVESTRE LEAF; ARGININE HYDROCHLORIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; PHYTONADIONE; VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; PANTOTHENIC ACID
Active strength
30; 15; 200; 100; 60; 13.5; 90; 900; 50; 18.75; 8; 4; 4; 24; 1000; 8; 8 ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Diatrol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIOTIN30 ug/1
VANADYL SULFATE15 mg/1
CHROMIUM NICOTINATE200 ug/1
GYMNEMA SYLVESTRE LEAF100 mg/1
ARGININE HYDROCHLORIDE60 ug/1
.ALPHA.-TOCOPHEROL ACETATE, DL-13.5 mg/1
PHYTONADIONE90 ug/1
VITAMIN A900 ug/1
ASCORBIC ACID50 mg/1
CHOLECALCIFEROL18.75 ug/1
PYRIDOXINE HYDROCHLORIDE8 mg/1
THIAMINE MONONITRATE4 mg/1
RIBOFLAVIN4 mg/1
NIACINAMIDE24 mg/1
LEVOMEFOLATE CALCIUM1000 ug/1
METHYLCOBALAMIN8 ug/1
PANTOTHENIC ACID8 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
015efbe7-5dcf-c8dc-f62d-817d23b49060Product name220250717
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-162-54Diatrol30 in 1 BOTTLE, PLASTICCAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-162-54EA - Each59088-162910bc4ff-8f13-4a70-888f-f7a7ffacbab512024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-162DIATROL (VITAMINS AND MINERAL) CAPSULE [PURETEK CORPORATION]2Current NDC, 1 package rows20240402_0fe2b1cf-9085-ea65-e063-6294a90a80a6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-162-545908801625430 TABLET in 1 BOTTLE, PLASTIC (59088-162-54) 30 tablet2024-01-26NoNoCurrent