Search by Drug Name or NDC
NDC 42192-0332-30 PNV-Omega 10; 85; 250; 140; 200; 12; 300; 28; 1; 40; 45; 150; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1 Details
PNV-Omega 10; 85; 250; 140; 200; 12; 300; 28; 1; 40; 45; 150; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1
PNV-Omega is a ORAL CAPSULE, GELATIN COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Acella Pharmaceuticals, LLC. The primary component is .ALPHA.-TOCOPHEROL; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; ICOSAPENT; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE.
Product Information
| NDC | 42192-0332 |
|---|---|
| Product ID | 42192-332_8c538001-443e-0ec7-e053-2995a90a218b |
| Associated GPIs | 78512062000130 |
| GCN Sequence Number | 066139 |
| GCN Sequence Number Description | mv-mins 71/iron/folic no.1/dha CAPSULE 28-1-300MG ORAL |
| HIC3 | C6Z |
| HIC3 Description | MULTIVITAMIN PREPARATIONS |
| GCN | 28345 |
| HICL Sequence Number | 036884 |
| HICL Sequence Number Description | MULTIVITAMIN-MINERALS NO.71/IRON FUMARAT/FOLIC ACID NO.1/DHA |
| Brand/Generic | Generic |
| Proprietary Name | PNV-Omega |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, cyanocobalamin, calcium corbonate, ferrous fumarate, potassium iodide, magnesium, doconexent, icosapent |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, GELATIN COATED |
| Route | ORAL |
| Active Ingredient Strength | 10; 85; 250; 140; 200; 12; 300; 28; 1; 40; 45; 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; ug/1; mg/1 |
| Substance Name | .ALPHA.-TOCOPHEROL; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; ICOSAPENT; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE |
| Labeler Name | Acella 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 42192-0332-30 (42192033230)
| NDC Package Code | 42192-332-30 |
|---|---|
| Billing NDC | 42192033230 |
| Package | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-332-30) |
| Marketing Start Date | 2010-08-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 735c5531-137f-4cee-8c68-ae121045a8ff Details
DESCRIPTION
PNV-Omega is a prescription prenatal/postnatal dietary supplement softgel capsule that contains multivitamins and minerals along with essential fatty acids. Each softgel is green in color, opaque and imprinted with “332” on one side.
OTHER INGREDIENTS
Gelatin capsule (bovine gelatin, glycerin, purified water, titanium dioxide, FD&C Yellow #5, FD&C Blue #1, and FD&C Yellow #6), soy lecithin, vegetable shortening, and yellow beeswax. Contains soy. Contains FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6.
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.
WARNING
PRECAUTIONS
ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
PNV - Omega is supplied in child-resistant bottles of 30 softgels (42192-332-30). The listed product is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable.
Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the dietary ingredients, other ingredients and information provided herein.
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.
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets
INGREDIENTS AND APPEARANCE
| PNV-OMEGA
ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, cyanocobalamin, calcium corbonate, ferrous fumarate, potassium iodide, magnesium, doconexent, icosapent capsule, gelatin coated |
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
| Labeler - Acella Pharmaceuticals, LLC (825380939) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Acella Pharmaceuticals, LLC | 825380939 | manufacture(42192-332) | |