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NDC 75854-0309-30 PRENATE Enhance 10; 85; 500; 155; 1000; 12; 400; 28; 1; 50; 150; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details

PRENATE Enhance 10; 85; 500; 155; 1000; 12; 400; 28; 1; 50; 150; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1

PRENATE Enhance 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 FUMARATE; FOLIC ACID; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE.

Product Information

NDC	75854-0309
Product ID	75854-309_b8552bf1-132c-4720-e053-2a95a90af78b
Associated GPIs	78516024000137
GCN Sequence Number	071461
GCN Sequence Number Description	prenatal vit68/iron/FA no6/dha CAPSULE 28-1-400MG ORAL
HIC3	C6F
HIC3 Description	PRENATAL VITAMIN PREPARATIONS
GCN	35262
HICL Sequence Number	040616
HICL Sequence Number Description	PRENATAL VITAMINS NO.68/IRON FUMARATE/FOLATE NO.6/DHA
Brand/Generic	Brand
Proprietary Name	PRENATE Enhance
Proprietary Name Suffix	n/a
Non-Proprietary Name	ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE, GELATIN COATED
Route	ORAL
Active Ingredient Strength	10; 85; 500; 155; 1000; 12; 400; 28; 1; 50; 150; 25
Active Ingredient Units	[iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
Substance Name	.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM OXIDE; POTASSIUM IODIDE; 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 75854-0309-30 (75854030930)

Pricing Information	N/A
NDC Package Code	75854-309-30
Billing NDC	75854030930
Package	30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-309-30)
Marketing Start Date	2013-10-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cf10de09-6ed5-4a66-84fa-2da4f668bbe6 Details

SPL UNCLASSIFIED SECTION

Rx postnatal vitamin with 400 mg DHA, 1,000 IU Vitamin D and chelated iron

Rx Only Dietary Supplement

SPL UNCLASSIFIED SECTION

DESCRIPTION: PRENATE ® Enhance is a prescription prenatal vitamin that contains 400 mg of DHA and advanced calcium. Each dark purple softgel is imprinted with N on one side and blank on the other.

SPL UNCLASSIFIED SECTION

OTHER INGREDIENTS: Gelatin capsule (FD&C Blue # 1, FD&C Red # 40, gelatin, glycerin, purified water, sorbitol, and titanium dioxide), palm shortening, soy lecithin and white beeswax.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

CONTRAINDICATIONS: PRENATE ® Enhance 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.

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: One softgel daily, or as directed by a physician.

SPL UNCLASSIFIED SECTION

HOW SUPPLIED: Bottles of 30 softgels (75854-309-30). 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

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

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC

Atlanta, GA 30005

1-888-61-AVION

Rev. 0319-01

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.

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

PRINCIPAL DISPLAY PANEL - 30 Softgel label

75854-309-30

PRENATE ®Enhance

Rx postnatal vitamin with probiotics and DHA,

1,000 IU Vitamin D and chelated iron

Rx Only

Dietary Supplement

30 Softgels

INGREDIENTS AND APPEARANCE

PRENATE ENHANCE

ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent capsule, gelatin coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:75854-309
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	85 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]
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	25 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	500 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	155 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	28 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	50 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	400 mg

Ingredient Name	Strength
Inactive Ingredients
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WHITE WAX (UNII: 7G1J5DA97F)
CORN OIL (UNII: 8470G57WFM)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	purple (dark purple)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	N
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75854-309-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/17/2013

Labeler - Avion Pharmaceuticals, LLC (040348516)

Name	Address	ID/FEI	Business Operations
Establishment
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-309)

Revised: 1/2021

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

Set id: cf10de09-6ed5-4a66-84fa-2da4f668bbe6

Version: 5

Effective Time: 20210107

Search by Drug Name or NDC

NDC 75854-0309-30 PRENATE Enhance 10; 85; 500; 155; 1000; 12; 400; 28; 1; 50; 150; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details

PRENATE Enhance 10; 85; 500; 155; 1000; 12; 400; 28; 1; 50; 150; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1

Product Information

Package

Package Images

NDC 75854-0309-30 (75854030930)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL cf10de09-6ed5-4a66-84fa-2da4f668bbe6 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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 - 30 Softgel label

INGREDIENTS AND APPEARANCE

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