Prenate Chewable

Product NDC
75854-306
11-digit product format
758540306
Labeler code
75854
Product ID
75854-306_a5b79773-2d3c-4549-8e10-11f8cce5809c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Avion Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-01-16
Substance
BILBERRY; BIOTIN; BORON; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE
Active strength
25; 280; 250; 500; 300; 125; 1; 50; 10 mg/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prenate Chewable
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BILBERRY25 mg/1
BIOTIN280 ug/1
BORON250 ug/1
CALCIUM CARBONATE500 mg/1
CHOLECALCIFEROL300 [iU]/1
CYANOCOBALAMIN125 mg/1
FOLIC ACID1 mg/1
MAGNESIUM OXIDE50 mg/1
PYRIDOXINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9P2U39H18W, 6SO6U10H04, N9E3X5056Q, H0G9379FGK, 1C6V77QF41, P6YC3EG204, 935E97BOY8, 3A3U0GI71G, 68Y4CF58BV

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
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efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
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91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
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11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
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0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
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87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75854-306-30Prenate Chewable30 in 1 BOTTLETABLET, CHEWABLE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75854-306-30EA - Each75854-3069b55b832-c13b-415f-96b4-6e77d72c05da12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BILBERRYACTIVE INGREDIENT9P2U39H18WPRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
BIOTINACTIVE INGREDIENT6SO6U10H04PRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
BORONACTIVE INGREDIENTN9E3X5056QPRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKPRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF41PRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204PRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
FOLIC ACIDACTIVE INGREDIENT935E97BOY8PRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
MAGNESIUM OXIDEACTIVE INGREDIENT3A3U0GI71GPRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BVPRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
BILBERRYACTIVE MOIETY9P2U39H18WPRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
BIOTINACTIVE MOIETY6SO6U10H04PRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
BORONACTIVE MOIETYN9E3X5056QPRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBPRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF41PRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204PRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
FOLIC ACIDACTIVE MOIETY935E97BOY8PRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838PRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZPRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
ACACIAINACTIVE INGREDIENT5C5403N26OPRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVPRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75854-306PRENATE CHEWABLE (CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BILBERRY) TABLET, CHEWABLE [AVION PHARMACEUTICALS, LLC]8Current NDC, Legacy NDC, 1 package rows20240123_917f02ce-51b9-4819-81e0-522842f6732a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75854-306-307585403063030 TABLET, CHEWABLE in 1 BOTTLE (75854-306-30) 2013-01-160000-00-00NoNoCurrent