Search by Drug Name or NDC

NDC 42192-0321-30 PNV-DHA 10; 85; 140; 200; 12; 300; 27; 1; 45; 25 [iU]/1; [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Details

PNV-DHA 10; 85; 140; 200; 12; 300; 27; 1; 45; 25 [iU]/1; [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; [iU]/1

PNV-DHA 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 ACETATE, DL-; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; PYRIDOXINE.

Product Information

NDC	42192-0321
Product ID	42192-321_620d0a13-cc62-6987-e053-2a91aa0a0690
Associated GPIs	78516024000125
GCN Sequence Number	065192
GCN Sequence Number Description	multivit 47/iron/folate 1/dha CAPSULE 27-1-300MG ORAL
HIC3	C6Z
HIC3 Description	MULTIVITAMIN PREPARATIONS
GCN	23495
HICL Sequence Number	036324
HICL Sequence Number Description	MULTIVITAMIN COMBINATION NO.47/FERROUS FUM/FOLATE NO.1/DHA
Brand/Generic	Generic
Proprietary Name	PNV-DHA
Proprietary Name Suffix	n/a
Non-Proprietary Name	ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE, GELATIN COATED
Route	ORAL
Active Ingredient Strength	10; 85; 140; 200; 12; 300; 27; 1; 45; 25
Active Ingredient Units	[iU]/1; [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; [iU]/1
Substance Name	.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; PYRIDOXINE
Labeler Name	Acella Pharmaceuticals, LLC
Pharmaceutical Class	Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitam
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 42192-0321-30 (42192032130)

Pricing Information
NDC Package Code	42192-321-30
Billing NDC	42192032130
Package	30 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-321-30)
Marketing Start Date	2009-11-02
NDC Exclude Flag	N
Price Per Unit	1.09317
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	PNV-DHA SOFTGEL
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 038fe2e7-dc16-485c-b5fb-746db7231347 Details

SPL UNCLASSIFIED SECTION

Rx Only

SPL UNCLASSIFIED SECTION

DESCRIPTION: PNV-DHA is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque and imprinted with “BP 321” on one side.

Supplement Facts
* Percent Daily Values are based on a 2000 calorie diet † Daily Value (DV) not established
Serving Size 1 Tablet
Amount Per Serving		% DV	%DV for Pregnant or Lactating Women
Vitamin C	85 mg	142%	142%
Vitamin D 3	200 IU	50%	50%
Vitamin E	10 IU	33%	33%
Vitamin D 6	25 mg	1250%	1000%
Folate	1 mg	250%	125%
(L-methylfolate calcium 676 mcg (as Xolafin-B™ *) molar equivalent to 600 mcg of Folic Acid)
(folic acid, USP 400 mcg)
Vitamin B 12	12 mcg	200%	150%
Calcium	140 mg	14%	11%
Iron (ferrous fumarate)	27 mg	150%	150%
Magnesium	45 mg	11%	10%
Docosahexaenoic Acid (DHA) (from omega-3 fatty acids)	300 mg	†	†

OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3.

INDICATIONS: PNV-DHA 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.

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

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.

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

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: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

SPL UNCLASSIFIED SECTION

HOW SUPPLIED: PNV-DHA is supplied in child-resistant bottles of 30 softgels (NDC# 42192-321-30).

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

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 active ingredients, excipients, inactive ingredients and chemical information provided herein.

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR: Acella Pharmaceuticals, LLC

9005 Westside Parkway

Alpharetta, GA 30009

1-800-541-4802

Rev. 04/10v6

*Xolafin-B™ is a trademark of Acella Pharmaceuticals, LLC

PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets

NDC 42192-321-30

PNV-DHA

Rx Prenatal Vitamin and DHA

Rx Only 30 Softgels

Acella

PHARMACEUTICALS, LLC

PRINCIPAL DISPLAY PANEL - Film Coated Tablets

INGREDIENTS AND APPEARANCE

PNV-DHA

ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent capsule, gelatin coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:42192-321
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 [iU]
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	200 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	10 [iU]
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	25 [iU]
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP)	CALCIUM	140 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A)	MAGNESIUM	45 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	300 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
CORN OIL (UNII: 8470G57WFM)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	25mm
Flavor		Imprint Code	BP;321
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42192-321-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/02/2009

Labeler - Acella Pharmaceuticals, LLC (825380939)

Name	Address	ID/FEI	Business Operations
Establishment
Acella Pharmaceuticals, LLC		825380939	manufacture(42192-321)

Revised: 1/2018

Document Id: 620d0a13-cc62-6987-e053-2a91aa0a0690

Set id: 038fe2e7-dc16-485c-b5fb-746db7231347

Version: 2

Effective Time: 20180105

Search by Drug Name or NDC

NDC 42192-0321-30 PNV-DHA 10; 85; 140; 200; 12; 300; 27; 1; 45; 25 [iU]/1; [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Details

PNV-DHA 10; 85; 140; 200; 12; 300; 27; 1; 45; 25 [iU]/1; [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; [iU]/1

Product Information

Package

Package Images

NDC 42192-0321-30 (42192032130)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 038fe2e7-dc16-485c-b5fb-746db7231347 Details

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

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets

INGREDIENTS AND APPEARANCE

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