Search by Drug Name or NDC

NDC 42192-0320-90 PNV-Select 10; 80; 300; 120; 6; 400; 2; 12; 27; 1; 30; 20; 150; 20; 3.4; 3; 2500; 15 [iU]/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; [iU]/1; ug/1 Details

PNV-Select 10; 80; 300; 120; 6; 400; 2; 12; 27; 1; 30; 20; 150; 20; 3.4; 3; 2500; 15 [iU]/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; [iU]/1; ug/1

PNV-Select is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Acella Pharmaceuticals, LLC. The primary component is .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLA.

Product Information

NDC	42192-0320
Product ID	42192-320_8c404ea3-e56f-123c-e053-2a95a90a65fb
Associated GPIs	78512022000320
GCN Sequence Number	064695
GCN Sequence Number Description	prenatal,calc.40/iron/folate 1 TABLET 27 MG-1 MG ORAL
HIC3	C6F
HIC3 Description	PRENATAL VITAMIN PREPARATIONS
GCN	16153
HICL Sequence Number	036026
HICL Sequence Number Description	PRENATAL VIT WITH CALCIUM NO.40/IRON FUMARATE/FOLATE NO.1
Brand/Generic	Generic
Proprietary Name	PNV-Select
Proprietary Name Suffix	n/a
Non-Proprietary Name	VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASS
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	10; 80; 300; 120; 6; 400; 2; 12; 27; 1; 30; 20; 150; 20; 3.4; 3; 2500; 15
Active Ingredient Units	[iU]/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; [iU]/1; ug/1
Substance Name	.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLA
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], 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 42192-0320-90 (42192032090)

Pricing Information	N/A
NDC Package Code	42192-320-90
Billing NDC	42192032090
Package	90 TABLET, FILM COATED in 1 BOTTLE (42192-320-90)
Marketing Start Date	2009-11-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9f4ce551-7a80-4ddb-a014-95c44b54a420 Details

SPL UNCLASSIFIED SECTION

Rx Only

SPL UNCLASSIFIED SECTION

DESCRIPTION: PNV-Select is a prescription prenatal dietary supplement tablet that contains multivitamins and minerals, which are delivered in the form of a white, oval, oil-and water-soluble, film-coated tablet debossed with “320” on one side.

OTHER INGREDIENTS: Dicalcium Phosphate, Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate, Film Coating (Hydroxy Propyl Methyl Cellulose, Triacetin, Titanium Dioxide).

SPL UNCLASSIFIED SECTION

INDICATIONS: PNV-Select is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

SPL UNCLASSIFIED SECTION

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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.

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

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.

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 tablet daily or as directed by a physician.

SPL UNCLASSIFIED SECTION

HOW SUPPLIED: PNV-Select is supplied in child-resistant bottles of 90 tablets (42192-320-90). 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.

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

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. 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.

MANUFACTURED FOR:

Acella Pharmaceuticals, LLC

Alpharetta, GA 30005

1-800-541-4802

Rev 0719-03

PRINCIPAL DISPLAY PANEL - Film Coated Tablets

NDC 42192-320-90

PNV-Select

Prenatal Multivitamin

Dietary Supplement

Film Coated Tablets

Rx Only 90 Tablets

Acella

PHARMACEUTICALS, LLC

INGREDIENTS AND APPEARANCE

PNV-SELECT

vitamin a acetate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, zinc oxide and cupric oxide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:42192-320
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	2500 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	80 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	10 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3.4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	20 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	300 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	6 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	120 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	30 ug
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15 ug
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	2 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	320
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42192-320-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/04/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		10/01/1990

Labeler - Acella Pharmaceuticals, LLC (825380939)

Registrant - Acella Pharmaceuticals, LLC (825380939)

Name	Address	ID/FEI	Business Operations
Establishment
Acella Pharmaceuticals, LLC		825380939	manufacture(42192-320)

Revised: 1/2020

Document Id: 8c404ea3-e56f-123c-e053-2a95a90a65fb

Set id: 9f4ce551-7a80-4ddb-a014-95c44b54a420

Version: 2

Effective Time: 20200117

Search by Drug Name or NDC

NDC 42192-0320-90 PNV-Select 10; 80; 300; 120; 6; 400; 2; 12; 27; 1; 30; 20; 150; 20; 3.4; 3; 2500; 15 [iU]/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; [iU]/1; ug/1 Details

PNV-Select 10; 80; 300; 120; 6; 400; 2; 12; 27; 1; 30; 20; 150; 20; 3.4; 3; 2500; 15 [iU]/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; [iU]/1; ug/1

Product Information

Package

Package Images

NDC 42192-0320-90 (42192032090)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 9f4ce551-7a80-4ddb-a014-95c44b54a420 Details

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

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - Film Coated Tablets

INGREDIENTS AND APPEARANCE

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