Search by Drug Name or NDC

NDC 75854-0316-30 Prenate Pixie 10; 30; 75; 5; 500; 13; 200; 10; 400; 600; 150; 5 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1 Details

Prenate Pixie 10; 30; 75; 5; 500; 13; 200; 10; 400; 600; 150; 5 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1

Prenate Pixie is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Avion Pharmaceuticals, LLC. The primary component is .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; BLUEBERRY; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCUSATE SODIUM; FERROUS ASPARTO GLYCINATE; FOLIC ACID; LEVOMEFOLIC ACID; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE.

Product Information

NDC	75854-0316
Product ID	75854-316_b8557aad-1596-b466-e053-2a95a90a5fec
Associated GPIs	78516025000115
GCN Sequence Number	072963
GCN Sequence Number Description	prenatal vit 85/iron/FA 1/dha CAPSULE 10-1-200MG ORAL
HIC3	C6F
HIC3 Description	PRENATAL VITAMIN PREPARATIONS
GCN	37274
HICL Sequence Number	041488
HICL Sequence Number Description	PRENATAL VITAMINS NO.85/IRON ASPARTO GLYCIN/FOLATE NO.1/DHA
Brand/Generic	Brand
Proprietary Name	Prenate Pixie
Proprietary Name Suffix	n/a
Non-Proprietary Name	ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docusate sodium and blueberry
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	10; 30; 75; 5; 500; 13; 200; 10; 400; 600; 150; 5
Active Ingredient Units	[iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1
Substance Name	.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; BLUEBERRY; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCUSATE SODIUM; FERROUS ASPARTO GLYCINATE; FOLIC ACID; LEVOMEFOLIC ACID; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE
Labeler Name	Avion Pharmaceuticals, LLC
Pharmaceutical Class	Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 75854-0316-30 (75854031630)

Pricing Information
NDC Package Code	75854-316-30
Billing NDC	75854031630
Package	30 TABLET, FILM COATED in 1 BOTTLE (75854-316-30)
Marketing Start Date	2014-08-15
NDC Exclude Flag	N
Price Per Unit	12.0263
Pricing Unit	EA
Effective Date	2024-01-01
NDC Description	PRENATE PIXIE SOFTGEL
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	4, 6
Classification for Rate Setting	B
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL fe0a737e-4f28-40d8-b4a7-090edf86a823 Details

SPL UNCLASSIFIED SECTION

Rx Only

DESCRIPTION: PRENATE PIXIE® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with “PIX”.

OTHER INGREDIENTS: Capsule gelatin (gelatin, glycerin, purified water, titanium dioxide, FD&C red #40, caramel, and FD&C blue #1), palm shortening, soy lecithin, and yellow beeswax. PRENATE PIXIE® contains fish oil and soy.

SPL UNCLASSIFIED SECTION

INDICATIONS: PRENATE PIXIE® is a multivitamin/multimineral fatty acid 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.

WARNING

WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

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 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

WARNING

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

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: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

SPL UNCLASSIFIED SECTION

HOW SUPPLIED: Bottles of 30 softgels (75854-0316-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

SPL UNCLASSIFIED SECTION

STORAGE: 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.

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

Sumalate® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC

Alpharetta, Georgia 30005

1-888-61-AVION

Rev. 0519-03

SPL UNCLASSIFIED SECTION

CONTRAINDICATIONS: PRENATE PIXIE® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

PRINCIPAL DISPLAY PANEL

75854-0316-30

Prenate pixie®

Robust Rx Prenatal Vitamin with

11 concentrated nutrients and minerals

in a tiny softgel package

SUGAR FREE

GLUTEN FREE

LACTOSE FREE

Rx Only

Dietary Supplement

30 Softgels

INGREDIENTS AND APPEARANCE

PRENATE PIXIE

ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docusate sodium and blueberry tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:75854-316
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	30 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	75 ug
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	500 [iU]
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	13 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	400 ug
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	10 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 ug
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	5 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	10 [iU]
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	200 mg
BLUEBERRY (UNII: 253RUG1X1A) (BLUEBERRY - UNII:253RUG1X1A)	BLUEBERRY	5 mg
LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	600 ug

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
YELLOW WAX (UNII: 2ZA36H0S2V)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CORN OIL (UNII: 8470G57WFM)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CARAMEL (UNII: T9D99G2B1R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)

Product Characteristics
Color	purple	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	PIX
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75854-316-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		08/15/2014

Labeler - Avion Pharmaceuticals, LLC (040348516)

Name	Address	ID/FEI	Business Operations
Establishment
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-316)

Revised: 1/2021

Document Id: b8557aad-1596-b466-e053-2a95a90a5fec

Set id: fe0a737e-4f28-40d8-b4a7-090edf86a823

Version: 10

Effective Time: 20210107

Search by Drug Name or NDC

NDC 75854-0316-30 Prenate Pixie 10; 30; 75; 5; 500; 13; 200; 10; 400; 600; 150; 5 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1 Details

Prenate Pixie 10; 30; 75; 5; 500; 13; 200; 10; 400; 600; 150; 5 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1

Product Information

Package

Package Images

NDC 75854-0316-30 (75854031630)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL fe0a737e-4f28-40d8-b4a7-090edf86a823 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

WARNING

SPL UNCLASSIFIED SECTION

WARNING

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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