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NDC 75854-0321-30 Niferex 60; 25; 50; 250; 100; 100; 750; 50; 15 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1 Details

Niferex 60; 25; 50; 250; 100; 100; 750; 50; 15 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1

Niferex is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Avion Pharmaceuticals, LLC. The primary component is ASCORBIC ACID; CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FOLIC ACID; INTRINSIC FACTOR; IRON DEXTRAN; LEVOMEFOLIC ACID; SUCCINIC ACID; ZINC.

Product Information

NDC	75854-0321
Product ID	75854-321_b8552673-ba5c-3d80-e053-2995a90a1fa5
Associated GPIs	82992000000300
GCN Sequence Number	077038
GCN Sequence Number Description	iron ag,ps/C/FA6/B12/Zn/sa/sto TABLET 150MG-60-1 ORAL
HIC3	C3B
HIC3 Description	IRON REPLACEMENT
GCN	42909
HICL Sequence Number	044048
HICL Sequence Number Description	IRON ASP GLY,POLYSACC/C/FOLATE 6/B12/ZINC GLY/SUCC AC/STOMCH
Brand/Generic	Brand
Proprietary Name	Niferex
Proprietary Name Suffix	n/a
Non-Proprietary Name	ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, succinic acid, and intrinsic factor
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	60; 25; 50; 250; 100; 100; 750; 50; 15
Active Ingredient Units	mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1
Substance Name	ASCORBIC ACID; CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FOLIC ACID; INTRINSIC FACTOR; IRON DEXTRAN; LEVOMEFOLIC ACID; SUCCINIC ACID; ZINC
Labeler Name	Avion Pharmaceuticals, LLC
Pharmaceutical Class	Ascorbic Acid [CS], Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 75854-0321-30 (75854032130)

Pricing Information	N/A
NDC Package Code	75854-321-30
Billing NDC	75854032130
Package	30 TABLET in 1 BOTTLE (75854-321-30)
Marketing Start Date	2017-01-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 899f97fb-85f1-4e78-9708-b916a1646129 Details

SPL UNCLASSIFIED SECTION

Rx Only Dietary Supplement

SPL UNCLASSIFIED SECTION

DESCRIPTION: Niferex™ for oral administrationis a prenatal/postnatal iron supplement that is a round, copper colored tablet with "NxFE" embossed on one side.

SPL UNCLASSIFIED SECTION

OTHER INGREDIENTS: Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Coating contains: HPMC, triacetin, titanium dioxide, Candurin® Orange (FD&C Blue #1, FD&C Red #40, FD&C Yellow #6). This product contains FD&C Yellow #6.

SPL UNCLASSIFIED SECTION

INDICATIONS: Niferex™ is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.

SPL UNCLASSIFIED SECTION

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

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.

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

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

SPL UNCLASSIFIED SECTION

DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by a physician.

SPL UNCLASSIFIED SECTION

HOW SUPPLIED: Bottles of 30 tablets (75854-321-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

SPL UNCLASSIFIED SECTION

STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

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

SPL UNCLASSIFIED SECTION

Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent #7,947,662 CAS #1181972-37-1

Sumalate® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 6,716,814, 8,007,846 and 8,425,956.

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC

Alpharetta, GA 30005 1-888-61-AVION

Rev. 0119-01 AV-428

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR INTENDED TO DIAGNOSE, PREVENT ANY DISEASE.

PRINCIPAL DISPLAY PANEL

Rx Only Dietary Supplement 75854-321-30

30 Tablets Sugar Free

Lactose Free

Niferex TM

www.niferexrx.com tablets

INGREDIENTS AND APPEARANCE

NIFEREX

ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, succinic acid, and intrinsic factor tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:75854-321
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	50 mg
IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	100 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	60 mg
LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	750 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	250 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	25 ug
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	15 mg
SUCCINIC ACID (UNII: AB6MNQ6J6L) (SUCCINIC ACID - UNII:AB6MNQ6J6L)	SUCCINIC ACID	50 mg
INTRINSIC FACTOR (UNII: 70BT6OQT2Q) (INTRINSIC FACTOR - UNII:70BT6OQT2Q)	INTRINSIC FACTOR	100 mg

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

Product Characteristics
Color	brown (copper colored)	Score	no score
Shape	ROUND	Size	19mm
Flavor		Imprint Code	NxFE
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75854-321-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		01/10/2017

Labeler - Avion Pharmaceuticals, LLC (040348516)

Registrant - Avion Pharmaceuticals, LLC (965450542)

Name	Address	ID/FEI	Business Operations
Establishment
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-321)

Revised: 1/2021

Document Id: b8552673-ba5c-3d80-e053-2995a90a1fa5

Set id: 899f97fb-85f1-4e78-9708-b916a1646129

Version: 5

Effective Time: 20210107

Search by Drug Name or NDC

NDC 75854-0321-30 Niferex 60; 25; 50; 250; 100; 100; 750; 50; 15 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1 Details

Niferex 60; 25; 50; 250; 100; 100; 750; 50; 15 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1

Product Information

Package

Package Images

NDC 75854-0321-30 (75854032130)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 899f97fb-85f1-4e78-9708-b916a1646129 Details

SPL UNCLASSIFIED SECTION

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WARNING

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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