MedPath

NeoMaterna

NeoMaternaPRENATAL/POSTNATAL Dietary Supplement

Approved
Approval ID

e5a019a2-d0de-4534-ba63-2ae7914bb8d6

Product Type

DIETARY SUPPLEMENT

Effective Date

May 23, 2025

Manufacturers
FDA

Trifluent Pharma

DUNS: 117167281

Products 1

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

BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, DL-ALPHA-TOCOPHERYL ACETATE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, 5-METHYL TETRAHYDROFOLATE, CALCIUM SALT, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS BISGLYCINATE, POTASSIUM IODINE, MAGNESIUM OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73352-891
Product Classification
G
Generic Name
BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, DL-ALPHA-TOCOPHERYL ACETATE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, 5-METHYL TETRAHYDROFOLATE, CALCIUM SALT, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS BISGLYCINATE, POTASSIUM IODINE, MAGNESIUM OXIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (22)

ASCORBIC ACIDActive
Quantity: 60 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
BETA CAROTENEActive
Quantity: 300 ug in 1 1
Code: 01YAE03M7J
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 10 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 45 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM
PYRIDOXINE HCLActive
Quantity: 26 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
FOLIC ACIDActive
Quantity: 1000 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
LEVOMEFOLATE CALCIUMActive
Quantity: 670 ug in 1 1
Code: A9R10K3F2F
Classification: ACTIM
CYANOCOBALAMINActive
Quantity: 13 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
BIOTINActive
Quantity: 28 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
CALCIUM CARBONATEActive
Quantity: 80 mg in 1 1
Code: H0G9379FGK
Classification: ACTIM
FERROUS BISGLYCINATEActive
Quantity: 20 mg in 1 1
Code: SFW1D987QV
Classification: ACTIM
POTASSIUM IODIDEActive
Quantity: 150 ug in 1 1
Code: 1C4QK22F9J
Classification: ACTIM
MAGNESIUM OXIDEActive
Quantity: 25 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIM
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

Label

image description

HEALTH CLAIM SECTION

LOINC: 69719-3Updated: 5/23/2025

DESCRIPTION

NeoMaterna is a prescription prenatal/postnatal multivitamin/ multimineral dietary supplement.

STATEMENT OF IDENTITY SECTION

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

NeoMterna- beta carotene, ascorbic acid, cholecalciferol, dl-alpha-tocopheryl acetate, pyridoxine hydrochloride, folic acid, 5-methyl tetrahydrofolate, calcium salt, cyanocobalamin, biotin, calcium carbonate, ferrous bisglycinate, potassium iodine, and magnesium oxide tablet.

Serving Size: 1 Tablet

Servings Per Container: 30

Each Tablet Contains:

%DV

Vitamin A (as Beta-Carotene)

300 mcg RAE

23%

Vitamin C (as ascorbic acid)

60 mg

50%

Vitamin D3 (as cholecalciferol)

10 mcg

67%

Vitamin E (as dl-Alpha-Tocopheryl Acetate)

45 mg

24%

Vitamin B6 (as pyridoxine HCl)

26 mg

1300%

Folate

(From Folic Acid)

(From 5-Methyl Tetrahydrofolate, Calcium Salt)

1670 mcg DFE

278%

Vitamin B12 (as Cyanocobalamine)

13 mcg

464%

Biotin

28 mg

80%

Calcium (from Calcium Carbonate)

80 mg

6%

FerrochelTM Iron (as ferrous BisGlycinate Chelate)

20 mg

44%

Iodine (as potassium iodide)

150 mcg

52%

Magnesium (as Magnesium oxide)

25 mg

6%

  • -Percent Daily Value for pregnant and/or lactating women

OTHER INGREDIENTS: Modified Cellulose, Stearic Acid, Croscarmellose Sodium, Silicon Dioxide, Magnesium Stearate, Polyethylene Glycol, Polydextrose, Titanium Dioxide, FD&C #1 Blue Lake

Allergen: NONE

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/23/2025

DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, one tablet daily with food or as directed by a physician.

SAFE HANDLING WARNING SECTION

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

STORAGE

Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light
and moisture.

Distributed by:

Trifluent Pharma, LLC.

San Antonio, TX

78213

Rev 01 05/2025

WARNINGS SECTION

LOINC: 34071-1Updated: 5/23/2025

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in Children under 6. Keep this product out of the reach of children. In the cse of acceidental overdose, call a docotr or poison control center immediately.

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