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NDC 75854-0313-30 Prenate Essential 10; 600; 90; 280; 155; 220; 13; 300; 18; 400; 40; 50; 150; 26 [iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1 Details
Prenate Essential 10; 600; 90; 280; 155; 220; 13; 300; 18; 400; 40; 50; 150; 26 [iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1
Prenate Essential 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-; 5-METHYLTETRAHYDROFOLIC ACID; ASCORBIC ACID; BIOTIN; CALCIUM FORMATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS ASPARTO GLYCINATE; FOLIC ACID; ICOSAPENT; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORI.
Product Information
| NDC | 75854-0313 |
|---|---|
| Product ID | 75854-313_b85520e4-ceed-3fd0-e053-2995a90a775d |
| Associated GPIs | 78516025000125 |
| GCN Sequence Number | 072897 |
| GCN Sequence Number Description | multivit no.40/iron/folat1/dha CAPSULE 18-1-300MG ORAL |
| HIC3 | C6Z |
| HIC3 Description | MULTIVITAMIN PREPARATIONS |
| GCN | 37203 |
| HICL Sequence Number | 041433 |
| HICL Sequence Number Description | MULTIVITAMIN NO.40/IRON ASPARTO GLYCINATE/FOLATE NO.1/DHA |
| Brand/Generic | Brand |
| Proprietary Name | Prenate Essential |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icos |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, GELATIN COATED |
| Route | ORAL |
| Active Ingredient Strength | 10; 600; 90; 280; 155; 220; 13; 300; 18; 400; 40; 50; 150; 26 |
| Active Ingredient Units | [iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1 |
| Substance Name | .ALPHA.-TOCOPHEROL ACETATE, DL-; 5-METHYLTETRAHYDROFOLIC ACID; ASCORBIC ACID; BIOTIN; CALCIUM FORMATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS ASPARTO GLYCINATE; FOLIC ACID; ICOSAPENT; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORI |
| 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 75854-0313-30 (75854031330)
| NDC Package Code | 75854-313-30 |
|---|---|
| Billing NDC | 75854031330 |
| Package | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-313-30) |
| Marketing Start Date | 2014-07-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e5acfb2a-0959-4542-9b4c-790be194d581 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INDICATIONS: PRENATE ESSENTIAL ® 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 ESSENTIAL ® can also be beneficial in improving the nutritional status of women prior to conception
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
HOW SUPPLIED: Bottles of 30 softgels (75854-313-30).
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
SPL UNCLASSIFIED SECTION
MANUFACTURED FOR: Avion Pharmaceuticals, LLC
Atlanta, GA 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
INGREDIENTS AND APPEARANCE
| PRENATE ESSENTIAL
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent capsule, gelatin coated |
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| Labeler - Avion Pharmaceuticals, LLC (040348516) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Avion Pharmaceuticals, LLC | 040348516 | manufacture(75854-313) | |