MedPath
FDA Approval

NeoMaterna

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Trifluent Pharma
DUNS: 117167281
Effective Date
May 23, 2025
Labeling Type
DIETARY SUPPLEMENT
Vitamin C(60 mg in 1 1)
Beta carotene(300 ug in 1 1)
Vitamin D3(10 ug in 1 1)
Pyridoxine(26 mg in 1 1)
Folic acid(1000 ug in 1 1)
levomefolate calcium(670 ug in 1 1)
Vitamin B12(13 ug in 1 1)
Biotin(28 ug in 1 1)
Calcium carbonate(80 mg in 1 1)
Ferrous bisglycinate(20 mg in 1 1)
Potassium Iodide(150 ug in 1 1)
Magnesium oxide(25 mg in 1 1)

Products1

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

NeoMaterna

Product Details

NDC Product Code
73352-891
Route of Administration
ORAL
Effective Date
May 23, 2025
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 60 mg in 1 1
Code: 01YAE03M7JClass: ACTIBQuantity: 300 ug in 1 1
Code: 1C6V77QF41Class: ACTIBQuantity: 10 ug in 1 1
Code: WR1WPI7EW8Class: ACTIMQuantity: 45 mg in 1 1
Code: 68Y4CF58BVClass: ACTIMQuantity: 26 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 1000 ug in 1 1
Code: A9R10K3F2FClass: ACTIMQuantity: 670 ug in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 13 ug in 1 1
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 28 ug in 1 1
Code: H0G9379FGKClass: ACTIMQuantity: 80 mg in 1 1
Code: SFW1D987QVClass: ACTIMQuantity: 20 mg in 1 1
Code: 1C4QK22F9JClass: ACTIMQuantity: 150 ug in 1 1
Code: 3A3U0GI71GClass: ACTIMQuantity: 25 mg in 1 1
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

image description

STATEMENT OF IDENTITY SECTION

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

DOSAGE AND ADMINISTRATION

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


WARNINGS SECTION

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.

SAFE HANDLING WARNING SECTION

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


HEALTH CLAIM SECTION

DESCRIPTION

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


© Copyright 2025. All Rights Reserved by MedPath