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NDC 75854-0320-30 Chromagen 60; 10; 25; 50; 250; 100; 750; 12 mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1 Details

Chromagen 60; 10; 25; 50; 250; 100; 750; 12 mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1

Chromagen is a ORAL CAPSULE 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; FERROUS FUMARATE; FOLIC ACID; INTRINSIC FACTOR; LEVOMEFOLIC ACID; ZINC.

Product Information

NDC	75854-0320
Product ID	75854-320_99eda51a-9427-65b5-e053-2a95a90ac430
Associated GPIs	82992000000100
GCN Sequence Number	077042
GCN Sequence Number Description	iron/C/folate 6/B12/Zn/stomach CAPSULE 75-60-1 MG ORAL
HIC3	C3B
HIC3 Description	IRON REPLACEMENT
GCN	42916
HICL Sequence Number	044047
HICL Sequence Number Description	IRON ASP GLY,FUMAR/VIT C/FOLATE 6/B12/ZINC GLY/STOMACH CONC
Brand/Generic	Brand
Proprietary Name	Chromagen
Proprietary Name Suffix	n/a
Non-Proprietary Name	ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, zinc, and intrinsic factor
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	60; 10; 25; 50; 250; 100; 750; 12
Active Ingredient Units	mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1
Substance Name	ASCORBIC ACID; CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; FOLIC ACID; INTRINSIC FACTOR; LEVOMEFOLIC ACID; ZINC
Labeler Name	Avion Pharmaceuticals, LLC
Pharmaceutical Class	Ascorbic Acid [CS], 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 75854-0320-30 (75854032030)

Pricing Information	N/A
NDC Package Code	75854-320-30
Billing NDC	75854032030
Package	30 CAPSULE in 1 BOTTLE (75854-320-30)
Marketing Start Date	2017-01-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 13c5ed58-6333-498f-9ace-1049d7ae3552 Details

SPL UNCLASSIFIED SECTION

Rx Only Dietary Supplement

SPL UNCLASSIFIED SECTION

DESCRIPTION: Chromagen™ for oral administration is a prenatal/postnatal iron supplement softgel that is pearlescent dark blue and embossed with “CH75” on one side.

SPL UNCLASSIFIED SECTION

OTHER INGREDIENTS: Gelatin capsule (bovine gelatin, Candurin® Blue Shimmer (mica-based pearlescent pigment), carob [St. John's Bread and Caramel], FD&C Blue #1, glycerin, purified water), soybean oil, soy lecithin and beeswax.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

CONTRAINDICATIONS: Chromagen™ 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 softgels (75854-320-30). 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. 0519-02 AV-426

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

75854-320-30

SUGAR FREE

LACTOSE FREE

Rx Only

Dietary Supplement

Chromagen™

30 softgels

INGREDIENTS AND APPEARANCE

CHROMAGEN

ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, zinc, and intrinsic factor capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:75854-320
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	25 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	50 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	10 ug
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	12 mg
INTRINSIC FACTOR (UNII: 70BT6OQT2Q) (INTRINSIC FACTOR - UNII:70BT6OQT2Q)	INTRINSIC FACTOR	100 mg

Ingredient Name	Strength
Inactive Ingredients
SOYBEAN OIL (UNII: 241ATL177A)
GELATIN TYPE B BOVINE (200 BLOOM) (UNII: A7JR5F8DLH)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CAROB (UNII: 5MG5Z946UO)
CARAMEL (UNII: T9D99G2B1R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
YELLOW WAX (UNII: 2ZA36H0S2V)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Product Characteristics
Color	blue (pearlescent dark blue)	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	CH75
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75854-320-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/23/2017

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)

Name	Address	ID/FEI	Business Operations
Establishment
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-320)

Revised: 1/2021

Document Id: 99eda51a-9427-65b5-e053-2a95a90ac430

Set id: 13c5ed58-6333-498f-9ace-1049d7ae3552

Version: 6

Effective Time: 20210118

Search by Drug Name or NDC

NDC 75854-0320-30 Chromagen 60; 10; 25; 50; 250; 100; 750; 12 mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1 Details

Chromagen 60; 10; 25; 50; 250; 100; 750; 12 mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1

Product Information

Package

Package Images

NDC 75854-0320-30 (75854032030)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 13c5ed58-6333-498f-9ace-1049d7ae3552 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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WARNING

SPL UNCLASSIFIED SECTION

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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