Search by Drug Name or NDC

NDC 75854-0306-30 Prenate Chewable 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 Details

Prenate Chewable 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

Prenate Chewable is a ORAL TABLET, CHEWABLE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Avion Pharmaceuticals, LLC. The primary component is BILBERRY; BIOTIN; BORON; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE.

Product Information

NDC	75854-0306
Product ID	75854-306_b85547d8-fce5-323d-e053-2995a90a4e7e
Associated GPIs	78510530000530
GCN Sequence Number	070467
GCN Sequence Number Description	multivitamin no.36/folate no.6 TAB CHEW 1 MG ORAL
HIC3	C6Z
HIC3 Description	MULTIVITAMIN PREPARATIONS
GCN	33993
HICL Sequence Number	039937
HICL Sequence Number Description	MULTIVITAMIN NO.36/METHYLTETRAHYDROFOLATE GLUC,FOLIC ACID
Brand/Generic	Brand
Proprietary Name	Prenate Chewable
Proprietary Name Suffix	n/a
Non-Proprietary Name	calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	25; 280; 250; 500; 300; 125; 1; 50; 10
Active Ingredient Units	mg/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1
Substance Name	BILBERRY; BIOTIN; BORON; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE
Labeler Name	Avion Pharmaceuticals, LLC
Pharmaceutical Class	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 Intest
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 75854-0306-30 (75854030630)

Pricing Information	N/A
NDC Package Code	75854-306-30
Billing NDC	75854030630
Package	30 TABLET, CHEWABLE in 1 BOTTLE (75854-306-30)
Marketing Start Date	2013-01-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 917f02ce-51b9-4819-81e0-522842f6732a Details

SPL UNCLASSIFIED SECTION

A chewable Rx prenatal vitamin with a delicious chocolate flavor

Rx Only

SPL UNCLASSIFIED SECTION

DESCRIPTION: PRENATE CHEWABLE ® is a prescription prenatal/postnatal multivitamin/mineral chocolate chewable tablet. Each tablet is brown and imprinted with "Prenate Chew" on one side and blank on the other.

SPL UNCLASSIFIED SECTION

OTHER INGREDIENTS: Chocolate Flavor, Gum Acacia, Fructose, Magnesium Stearate, Natural Dutch Chocolate, Silicone Dioxide and Silica (as Sipernat ®), and Hydrogenated Vegetable Oil (as Sterotex ®).

SPL UNCLASSIFIED SECTION

INDICATIONS: PRENATE CHEWABLE ® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE CHEWABLE ™ can also be beneficial in improving the nutritional status of women prior to conception.

SPL UNCLASSIFIED SECTION

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

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

SPL UNCLASSIFIED SECTION

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

SPL UNCLASSIFIED SECTION

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

SPL UNCLASSIFIED SECTION

DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.

SPL UNCLASSIFIED SECTION

HOW SUPPLIED: PRENATE CHEWABLE ® is supplied in child-resistant bottles of 30 tablets (75854-306-30).

The listed product number is not a National Drug Code, but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

SPL UNCLASSIFIED SECTION

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

SPL UNCLASSIFIED SECTION

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

MANUFACTURED FOR: Avion Pharmaceuticals, LLC

Atlanta, GA 30350

1-888-61-AVION

*Quatrefolic ® is a registered trademark of Gnosis, SpA.Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1

Rev. 0619-05

PRINCIPAL DISPLAY PANEL

75854-306-30

Prenate chewable ®

A chewable Rx prenatal vitamin with a delicious chocolate flavor

with Quatrefolic®

Dietary Supplement

30 Tablets

Rx Only

Avion

PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

PRENATE CHEWABLE

calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry tablet, chewable

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:75854-306
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	500 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	300 [iU]
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	50 mg
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q)	BORON	250 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	125 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	280 ug
BILBERRY (UNII: 9P2U39H18W) (BILBERRY - UNII:9P2U39H18W)	BILBERRY	25 mg

Ingredient Name	Strength
Inactive Ingredients
FRUCTOSE (UNII: 6YSS42VSEV)
ACACIA (UNII: 5C5403N26O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	brown	Score	2 pieces
Shape	ROUND	Size	22mm
Flavor	CHOCOLATE	Imprint Code	PrenateChew
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75854-306-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		01/16/2013

Labeler - Avion Pharmaceuticals, LLC (040348516)

Name	Address	ID/FEI	Business Operations
Establishment
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-306)

Revised: 1/2021

Document Id: b85547d8-fce5-323d-e053-2995a90a4e7e

Set id: 917f02ce-51b9-4819-81e0-522842f6732a

Version: 7

Effective Time: 20210107

Search by Drug Name or NDC

NDC 75854-0306-30 Prenate Chewable 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 Details

Prenate Chewable 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

Product Information

Package

Package Images

NDC 75854-0306-30 (75854030630)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 917f02ce-51b9-4819-81e0-522842f6732a Details

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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