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NDC 75854-0312-30 PRENATE DHA 40; 90; 155; 400; 25; 300; 18; 1; 50; 26 [iU]/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details

PRENATE DHA 40; 90; 155; 400; 25; 300; 18; 1; 50; 26 [iU]/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1

PRENATE DHA is a ORAL CAPSULE, GELATIN COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Avion Pharmaceuticals, LLC. The primary component is .ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; CALCIUM FORMATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS ASPARTO GLYCINATE; FOLIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE.

Product Information

NDC	75854-0312
Product ID	75854-312_b8552bf1-132f-4720-e053-2a95a90af78b
Associated GPIs	78516025000125
GCN Sequence Number	072472
GCN Sequence Number Description	prenatal 78/iron/folate 1/dha CAPSULE 18-1-300MG ORAL
HIC3	C6F
HIC3 Description	PRENATAL VITAMIN PREPARATIONS
GCN	36696
HICL Sequence Number	041203
HICL Sequence Number Description	PRENATAL VITAMINS NO.78/IRON ASPARTO GLYCIN/FOLATE NO.1/DHA
Brand/Generic	Brand
Proprietary Name	PRENATE DHA
Proprietary Name Suffix	n/a
Non-Proprietary Name	ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE, GELATIN COATED
Route	ORAL
Active Ingredient Strength	40; 90; 155; 400; 25; 300; 18; 1; 50; 26
Active Ingredient Units	[iU]/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1
Substance Name	.ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; CALCIUM FORMATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS ASPARTO GLYCINATE; FOLIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE
Labeler Name	Avion Pharmaceuticals, LLC
Pharmaceutical Class	Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inh
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 75854-0312-30 (75854031230)

Pricing Information
NDC Package Code	75854-312-30
Billing NDC	75854031230
Package	30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-312-30)
Marketing Start Date	2014-06-05
NDC Exclude Flag	N
Price Per Unit	9.54766
Pricing Unit	EA
Effective Date	2021-01-30
NDC Description	PRENATE DHA SOFTGEL
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	4, 6
Classification for Rate Setting	B
As of Date	2022-01-12

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 8f2eca71-9a82-4a19-9206-36a04b865fe1 Details

SPL UNCLASSIFIED SECTION

Rx Only Dietary Supplement

SPL UNCLASSIFIED SECTION

DESCRIPTION: PRENATE DHA ® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque, and imprinted with “DHA” on one side and blank on the other.

PRENATE DHA ® contains fish oil and soy.

SPL UNCLASSIFIED SECTION

OTHER INGREDIENTS: Gelatin capsule (FD&C Blue #1, FD&C Red #3, gelatin, glycerin, purified water, sorbitol and titanium dioxide), soybean oil, soy lecithin, and white beeswax.

SPL UNCLASSIFIED SECTION

INDICATIONS: PRENATE DHA ® 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. PRENATE DHA ® can also be beneficial in improving the nutritional status of women prior to conception.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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 B 12 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 (75854-312-30).

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

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

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC

Alpharetta, Georgia 30005

1-888-61-AVION

SPL UNCLASSIFIED SECTION

Formical ® is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542.

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.

PRENATE ® is a registered trademark of Avion Pharmaceuticals, LLC. Under license from Avion Pharmaceuticals, LLC.

Rev. 0519-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-312-30

Prenate DHA ®

Rx prenatal vitamin & DHA

Key vitamins, minerals, and DHA support nutrition

GLUTEN FREE

Rx Only

Dietary Supplement

30 Softgels

INGREDIENTS AND APPEARANCE

PRENATE DHA

ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent capsule, gelatin coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:75854-312
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	90 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	40 [iU]
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	26 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	25 ug
CALCIUM FORMATE (UNII: NP3JD65NPY) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	155 mg
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	18 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	50 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	300 mg

Ingredient Name	Strength
Inactive Ingredients
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SOYBEAN OIL (UNII: 241ATL177A)
WHITE WAX (UNII: 7G1J5DA97F)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)

Product Characteristics
Color	blue (opaque)	Score	no score
Shape	OVAL	Size	24mm
Flavor		Imprint Code	301
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75854-312-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/05/2014

Labeler - Avion Pharmaceuticals, LLC (040348516)

Registrant - Avion Pharmaceuticals, LLC (965450542)

Name	Address	ID/FEI	Business Operations
Establishment
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-312)

Revised: 1/2021

Document Id: b8552bf1-132f-4720-e053-2a95a90af78b

Set id: 8f2eca71-9a82-4a19-9206-36a04b865fe1

Version: 6

Effective Time: 20210107

Search by Drug Name or NDC

NDC 75854-0312-30 PRENATE DHA 40; 90; 155; 400; 25; 300; 18; 1; 50; 26 [iU]/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details

PRENATE DHA 40; 90; 155; 400; 25; 300; 18; 1; 50; 26 [iU]/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1

Product Information

Package

Package Images

NDC 75854-0312-30 (75854031230)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 8f2eca71-9a82-4a19-9206-36a04b865fe1 Details

SPL UNCLASSIFIED SECTION

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WARNING

SPL UNCLASSIFIED SECTION

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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