Search by Drug Name or NDC

NDC 75854-0314-30 Prenate Elite 40; 2600; 600; 75; 330; 155; 600; 1.5; 13; 20; 400; 25; 21; 150; 21; 3.5; 3; 15 [iU]/1; [iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Details

Prenate Elite 40; 2600; 600; 75; 330; 155; 600; 1.5; 13; 20; 400; 25; 21; 150; 21; 3.5; 3; 15 [iU]/1; [iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1

Prenate Elite is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Avion Pharmaceuticals, LLC. The primary component is .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; 5-METHYLTETRAHYDROFOLIC ACID; ASCORBIC ACID; BIOTIN; CALCIUM FORMATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; P.

Product Information

NDC	75854-0314
Product ID	75854-314_b8552bf1-132e-4720-e053-2a95a90af78b
Associated GPIs	78512012200330
GCN Sequence Number	072474
GCN Sequence Number Description	prenatal 114/iron a-g/folate 1 TABLET 20 MG-1 MG ORAL
HIC3	C6F
HIC3 Description	PRENATAL VITAMIN PREPARATIONS
GCN	36698
HICL Sequence Number	041205
HICL Sequence Number Description	PRENATAL VITS NO.114/FERROUS ASPART GLYCINATE/FOLATE NO.1
Brand/Generic	Brand
Proprietary Name	Prenate Elite
Proprietary Name Suffix	n/a
Non-Proprietary Name	.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, calcium formate, ferrous asparto glycinate, cyanocobalamin
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	40; 2600; 600; 75; 330; 155; 600; 1.5; 13; 20; 400; 25; 21; 150; 21; 3.5; 3; 15
Active Ingredient Units	[iU]/1; [iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1
Substance Name	.ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; 5-METHYLTETRAHYDROFOLIC ACID; ASCORBIC ACID; BIOTIN; CALCIUM FORMATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; P
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], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagul
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 75854-0314-30 (75854031430)

Pricing Information	N/A
NDC Package Code	75854-314-30
Billing NDC	75854031430
Package	30 TABLET, COATED in 1 BOTTLE (75854-314-30)
Marketing Start Date	2014-06-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9b79c950-4312-4a53-9e36-fb8e00b053df Details

SPL UNCLASSIFIED SECTION

Rx Only Dietary Supplement

SPL UNCLASSIFIED SECTION

DESCRIPTION: PRENATE ELITE ® is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with “PN” on one side and blank on the other.

SPL UNCLASSIFIED SECTION

OTHER INGREDIENTS: Microcrystalline Cellulose, Silicon Dioxide, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Film Coating (Hydroxypropyl Methylcellulose, Triacetin, Titanium Dioxide).

SPL UNCLASSIFIED SECTION

INDICATIONS: PRENATE ELITE ® 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.

SPL UNCLASSIFIED SECTION

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

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 tablet daily or as directed by a physician.

SPL UNCLASSIFIED SECTION

HOW SUPPLIED: Bottles of 30 tablets (75854-314-30). 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

Rev. 0519-01

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-314-30

Prenate Elite ®

PRENATAL VITAMINS-FILM-COATED TABLETS

GLUTEN FREE

Rx Only

Dietary Supplement

30 Tablets

INGREDIENTS AND APPEARANCE

PRENATE ELITE

.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:75854-314
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.BETA.-CAROTENE	2600 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	75 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	600 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	40 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3.5 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	21 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	21 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	400 ug
5-METHYLTETRAHYDROFOLIC ACID (UNII: TYK22LML8F) (5-METHYLTETRAHYDROFOLIC ACID - UNII:TYK22LML8F)	5-METHYLTETRAHYDROFOLIC ACID	600 ug
CALCIUM FORMATE (UNII: NP3JD65NPY) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	155 mg
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	20 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	13 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	330 ug
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	25 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	1.5 mg

Ingredient Name	Strength
Inactive Ingredients
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TRIACETIN (UNII: XHX3C3X673)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	PN
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75854-314-30	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)

Name	Address	ID/FEI	Business Operations
Establishment
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-314)

Revised: 1/2021

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

Set id: 9b79c950-4312-4a53-9e36-fb8e00b053df

Version: 5

Effective Time: 20210107

Search by Drug Name or NDC

NDC 75854-0314-30 Prenate Elite 40; 2600; 600; 75; 330; 155; 600; 1.5; 13; 20; 400; 25; 21; 150; 21; 3.5; 3; 15 [iU]/1; [iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Details

Prenate Elite 40; 2600; 600; 75; 330; 155; 600; 1.5; 13; 20; 400; 25; 21; 150; 21; 3.5; 3; 15 [iU]/1; [iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1

Product Information

Package

Package Images

NDC 75854-0314-30 (75854031430)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 9b79c950-4312-4a53-9e36-fb8e00b053df Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

WARNING

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?