MedPath

PNV 27-Ca/Fe/FA

PNV 27-Ca/Fe/FA

Approved
Approval ID

b1e8552f-e552-48ee-95bd-0a346794314e

Product Type

DIETARY SUPPLEMENT

Effective Date

May 27, 2025

Manufacturers
FDA

Westminster Pharmaceuticals, LLC

DUNS: 079516651

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

VITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69367-193
Product Classification
G
Generic Name
VITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (30)

VITAMIN A ACETATEActive
Quantity: 3600 [iU] in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
BETA CAROTENEActive
Quantity: 400 [iU] in 1 1
Code: 01YAE03M7J
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 80 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 400 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 15 [iU] in 1 1
Code: WR1WPI7EW8
Classification: ACTIM
THIAMINE MONONITRATEActive
Quantity: 1.5 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
RIBOFLAVINActive
Quantity: 1.6 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NIACINAMIDEActive
Quantity: 17 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 2.5 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
BIOTINActive
Quantity: 30 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
CALCIUM PANTOTHENATEActive
Quantity: 7 mg in 1 1
Code: 568ET80C3D
Classification: ACTIM
CALCIUM CARBONATEActive
Quantity: 200 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
FERROUS FUMARATEActive
Quantity: 60 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
MAGNESIUM OXIDEActive
Quantity: 100 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
ZINC OXIDEActive
Quantity: 25 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIB
CUPRIC OXIDEActive
Quantity: 3 mg in 1 1
Code: V1XJQ704R4
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POTASSIUM CITRATE ANHYDROUSInactive
Code: 86R1NVR0HW
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/27/2025

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

69367-193-01
Rx

PNV 27-Ca/Fe/FA
(one tablet daily)

Prenatal Multivitamin/
Multimineral Tablet

100 Tablets

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

HEALTH CLAIM SECTION

LOINC: 69719-3Updated: 5/27/2025

Manufactured for:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217

Rev. 12/24

STATEMENT OF IDENTITY SECTION

LOINC: 69718-5Updated: 5/27/2025

Supplement Facts
Serving Size: 1 Tablet

Amount Per Serving

%DV Pregnant and Lactating Women

  • Equal to mg alpha-tocopherol

Vitamin A (Acetate 3600 IU & Beta Carotene 400 IU)

1200 mcg RAE

92%

Vitamin C (Ascorbic Acid)

80 mg

67%

Vitamin D (as Cholecalciferol)

10 mcg (400 IU)

67%

Vitamin E (as dl-Alpha Tocopheryl Acetate)

7 mg* (15 IU)

37%

Thiamin (as Thiamine Mononitrate)

1.5 mg

107%

Riboflavin

1.6 mg

100%

Niacin (as Niacinamide)

17 mg NE

94%

Vitamin B6 (as Pyridoxine HCl)

4 mg

200%

Folate (as Folic Acid)

1667 mcg DFE
(1000 mcg folic acid)

278%

Vitamin B12 ( as Cyanocobalamin)

2.5 mcg

89%

Biotin

30 mcg

86%

Pantothenic Acid (as Calcium Pantothenate)

7 mg

100%

Calcium (as Calcium Carbonate)

200 mg

15%

Iron (as Ferrous Fumarate)

60 mg

222%

Magnesium (as Magnesium oxide)

100 mg

25%

Zinc (as Zinc Oxide)

25 mg

192%

Copper (as Cupric Oxide)

3 mg

231%

Other ingredients: Microcrystalline cellulose, potassium citrate, croscarmellose sodium, citric acid, stearic acid, povidone K30, acacia, magnesium stearate, hypromellose, fumed silica, titanium dioxide, polyethylene glycol.

WARNINGS SECTION

LOINC: 34071-1Updated: 5/27/2025

WARNINGS

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.

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 5/27/2025

PRECAUTIONS

General

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 0.1 mg daily may obscure pernicious anemia assessment, such that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia. The calcium content should be considered before prescribing for patients with history of kidney stones. Do not exceed the recommended dose.

Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic tests (e.g. troponin) and hormone test, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the- counter medicines, vitamins, and dietary supplements that you take, including biotin.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/27/2025

DIRECTIONS FOR USE

Take One (1) tablet daily or as prescribed by a physician.

SAFE HANDLING WARNING SECTION

LOINC: 50741-8Updated: 5/27/2025

KEEP OUT OF REACH OF CHILDREN.

For use on the order of a healthcare practitioner.

To report a serious adverse event contact: 1-844-221-7294

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PNV 27-Ca/Fe/FA - FDA Drug Approval Details