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NDC 75854-0315-30 Prenate Mini 10; 60; 280; 80; 1000; 13; 350; 9; 400; 9; 600; 25; 25; 150; 26 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1 Details

Prenate Mini 10; 60; 280; 80; 1000; 13; 350; 9; 400; 9; 600; 25; 25; 150; 26 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1

Prenate Mini 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 ACETATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS ASPARTO GLYCINATE; FOLIC ACID; IRON; LEVOMEFOLIC ACID; LOWBUSH BLUEBERRY; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCH.

Product Information

NDC	75854-0315
Product ID	75854-315_b8552bf1-1327-4720-e053-2a95a90af78b
Associated GPIs	78516042000125
GCN Sequence Number	073136
GCN Sequence Number Description	prenatal vit 87/iron/folic/dha CAPSULE 18-1-350MG ORAL
HIC3	C6F
HIC3 Description	PRENATAL VITAMIN PREPARATIONS
GCN	37468
HICL Sequence Number	041593
HICL Sequence Number Description	PRENATAL VITS NO.87/IRON CARB-ASP.GLYCINATE/FOLATE NO.1/DHA
Brand/Generic	Brand
Proprietary Name	Prenate Mini
Proprietary Name Suffix	n/a
Non-Proprietary Name	ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous asparto glycinate, iron, potassium iodide, magnesium oxide, doconexent and lowbush blueberry
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE, GELATIN COATED
Route	ORAL
Active Ingredient Strength	10; 60; 280; 80; 1000; 13; 350; 9; 400; 9; 600; 25; 25; 150; 26
Active Ingredient Units	[iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1
Substance Name	.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS ASPARTO GLYCINATE; FOLIC ACID; IRON; LEVOMEFOLIC ACID; LOWBUSH BLUEBERRY; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCH
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 75854-0315-30 (75854031530)

Pricing Information
NDC Package Code	75854-315-30
Billing NDC	75854031530
Package	30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-315-30)
Marketing Start Date	2014-11-18
NDC Exclude Flag	N
Price Per Unit	12.0914
Pricing Unit	EA
Effective Date	2024-01-01
NDC Description	PRENATE MINI 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 8ab766c2-d554-4141-92b2-fbe038e80c9f Details

SPL UNCLASSIFIED SECTION

Rx Only Dietary Supplement

SPL UNCLASSIFIED SECTION

DESCRIPTION: PRENATE MINI ® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each oval softgel is teal green in color and imprinted with “Mini”.

Contains fish oil and soy. Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

SPL UNCLASSIFIED SECTION

OTHER INGREDIENTS: Bovine gelatin, FD&C Blue #1, FD&C Yellow #5, fish (tuna) oil, glycerin, purified water, soy lecithin, titanium dioxide, vegetable shortening and yellow beeswax.

SPL UNCLASSIFIED SECTION

INDICATIONS: PRENATE MINI ® 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.

PRENATEMINI ® can also be beneficial in improving the nutritional status of women prior to conception.

SPL UNCLASSIFIED SECTION

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

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. This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

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 (75854-0315-30). 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

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC

Alpharetta, GA 30005

1-888-61-AVION

Rev. 0519-01

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

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-0315-30

Rx Only Dietary Supplement

Prenate mini ®

A small, easy-to-swallow

softgel with complete prenatal

nutrition support, including

350 mg of DHA

30 Softgels

SUGAR FREE

GLUTEN FREE

LACTOSE FREE

Avion

PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

PRENATE MINI

ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous asparto glycinate, iron, potassium iodide, magnesium oxide, doconexent and lowbush blueberry capsule, gelatin coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:75854-315
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	280 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	80 mg
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	9 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	9 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	25 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	350 mg
LOWBUSH BLUEBERRY (UNII: G90PX41VP0) (ICOSAPENT - UNII:AAN7QOV9EA)	LOWBUSH BLUEBERRY	25 mg
LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	600 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	60 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	1000 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	10 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	26 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	400 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	13 ug

Ingredient Name	Strength
Inactive Ingredients
FISH OIL (UNII: XGF7L72M0F)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
YELLOW WAX (UNII: 2ZA36H0S2V)
WATER (UNII: 059QF0KO0R)
CORN OIL (UNII: 8470G57WFM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	green (teal green)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	Mini
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75854-315-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/18/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/18/2014

Labeler - Avion Pharmaceuticals, LLC (040348516)

Name	Address	ID/FEI	Business Operations
Establishment
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-315)

Revised: 1/2021

Document Id: b8552bf1-1327-4720-e053-2a95a90af78b

Set id: 8ab766c2-d554-4141-92b2-fbe038e80c9f

Version: 12

Effective Time: 20210107

Search by Drug Name or NDC

NDC 75854-0315-30 Prenate Mini 10; 60; 280; 80; 1000; 13; 350; 9; 400; 9; 600; 25; 25; 150; 26 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1 Details

Prenate Mini 10; 60; 280; 80; 1000; 13; 350; 9; 400; 9; 600; 25; 25; 150; 26 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1

Product Information

Package

Package Images

NDC 75854-0315-30 (75854031530)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 8ab766c2-d554-4141-92b2-fbe038e80c9f Details

SPL UNCLASSIFIED SECTION

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WARNING

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WARNING

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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