Hematogen

Ferrous Fumarate, Ascorbic Acid, Intrinsic Factor , Cyanocobalamin


Nnodum Pharmaceuticals
Human Prescription Drug
NDC 63044-631
Hematogen also known as Ferrous Fumarate, Ascorbic Acid, Intrinsic Factor , Cyanocobalamin is a human prescription drug labeled by 'Nnodum Pharmaceuticals'. National Drug Code (NDC) number for Hematogen is 63044-631. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Hematogen drug includes Ascorbic Acid - 250 mg/1 Cyanocobalamin - 10 ug/1 Ferrous Fumarate - 66 mg/1 Intrinsic Factor - 100 mg/1 . The currest status of Hematogen drug is Active.

Drug Information:

Drug NDC: 63044-631
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Hematogen
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Ferrous Fumarate, Ascorbic Acid, Intrinsic Factor , Cyanocobalamin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Nnodum Pharmaceuticals
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Capsule
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ASCORBIC ACID - 250 mg/1
CYANOCOBALAMIN - 10 ug/1
FERROUS FUMARATE - 66 mg/1
INTRINSIC FACTOR - 100 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 10 May, 2007
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 13 Jan, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Nnodum Pharmaceuticals
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:N0000193618
M0001797
M0022794
N0000175951
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:PQ6CK8PD0R
P6YC3EG204
R5L488RY0Q
70BT6OQT2Q
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Vitamin C [EPC]
Vitamin B12 [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:Ascorbic Acid [CS]
Vitamin B 12 [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Ascorbic Acid [CS]
Vitamin B 12 [CS]
Vitamin B12 [EPC]
Vitamin C [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
63044-631-19100 BLISTER PACK in 1 BOX (63044-631-19) / 1 CAPSULE in 1 BLISTER PACK10 May, 2007N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Hematogen ferrous fumarate, ascorbic acid, intrinsic factor , cyanocobalamin ferrous fumarate ferrous cation ascorbic acid ascorbic acid intrinsic factor intrinsic factor cyanocobalamin cyanocobalamin ziks;631

Indications and Usage:

Indications: for the treatment of all anemias responsive to oral iron therapy, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence.

Dosage and Administration:

Dosage and administration: usual adult dose is 1 soft gelatin capsule daily.

Contraindications:

Contraindications: hemochromatosis and hemosiderosis are contraindications to iron therapy. warning: accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. keep this product out of reach of children. in case of accidental overdose, call a doctor or poison control center immediately.

Adverse Reactions:

Adverse reactions: average capsule doses in sensitive individuals or excessive dosage may cause nausea, skin rash, vomiting, diarrhea, precordial pain, or flushing of the face or extremities.

Clinical Pharmacology:

Actions/clinical pharmacology high elemental iron content: ferrous fumarate, used in hematogen™ capsules, is an organic iron complex which has the highest elemental iron content of any hematinic salt-33%. this compares with 20% for ferrous sulfate (heptahydrate) and 13% for ferrous gluconate. hematogen™ contains 66 mg of elemental iron. more complete absorption: it has been repeatedly shown that ascorbic acid, when given in sufficient amounts, can increase the absorption of ferrous iron from the gastrointestinal tract. the absorption promoting effect is mainly due to the reducing action of ascorbic acid within the gastro intestinal lumen, which helps to prevent or delay the formation of insoluble or less dissociated ferric compounds. iron absorption has been shown to increase sharply with increasing amounts of ascorbic acid, showing a gain in absorption of approximately 40% at 250 mg. above 250 mg, the gain becomes insignificant, with an additional gain of only approximately
8% at 500 mg. each hematogen™ capsule contains 250 mg of ascorbic acid, believed to be the optimal amount. promotes movement of plasma iron: ascorbic acid also plays an important role in the movement of plasma iron to storage depots in the tissues . the action, which leads to the transport of plasma iron to ferritin, presumably involves its reducing effect; converting transferrin iron from 5 the ferric to the ferrous state. there is also evidence that ascorbic acid improves iron utilization, presumably as a further result of its reducing action , and some evidence that it may have a direct effect upon erythropoiesis. ascorbic acid is further alleged to enhance the conversion of folic acid to a more physiologically active form, folinic acid. which would make it even more important in the 11 treatment of anemia since it would aid in the utilization of dietary folic acid. excellent oral toleration: ferrous fumarate is used in hematogen™ capsules because it is less likely to cause the gastric disturbances so often associated with oral iron therapy. ferrous fumarate has a low ionization constant and high solubility in the entire ph range of the gastrointestinal tract. it does not precipitate proteins or have the astringency of more ionizable forms of iron, and does not interfere with proteolytic or diastatic activities of the digestive system. because of excellent oral toleration, hematogen™ capsules can usually be administered between meals when iron absorption is maximal. facilitates absorption of vitamin b12 : it is now known that "intrinsic factor" is essential for the adequate alimentary absorption of vitamin b. the inclusion of desiccated stomach powder 12 with oral vitamin b will furnish sufficient intrinsic factor to assure absorption of the vitamin 12 only toxicity: ferrous fumarate was found to be the least toxic of three popular oral iron salts, with an oral ld50 of 630 mg/kg. in the same report, the ld50 of ferrous gluconate was reported to be 320 mg/kg and ferrous sulfate 230 mg/kg.

How Supplied:

How supplied: each red soft gelatin capsule is imprinted with "ziks631" on one side. ndc 63044-0631-19 10 x 10, unit dose packs, in packs of 100's. store at controlled between temperature 15°- 30°c (59°- 86°f). protect from direct / excessive heat 40°c (104°f). avoid freezing. 1 bibliography: berk, m.s. and novich, m.a.: 'treatment of iron deficiency anemia with ferrous 2 fumarate," am. j. obst. & gynec., 203-206, 1962. shapleigh, j.b., and montgomery, a.; am. pract. & 3 dig. treat. 10-461, 1959. brise, h. and hallberg, l.: "effect of ascorbic acid on iron absorption," acta. 4 5 med. scand. 171 :376, 51 -58,1962. new drugs, p. 309, ama, chicago, 1966. mazur, a., green, s. and carleton, a.: "mechanism of plasma iron incorporation into hepatic ferritin," j. of bio. chem. 6 3:595-603, 1960. greenberg, s.m., tucker, a.e., mathues, h. and j.d.: "iron absorption and 7 metabolism, i. interrelationship of ascorbic acid and vitamin e," j. nutrition 63:19-31, 1957. moore, c. v.
, and dubach, r.: "observations on the absorption of iron from foods tagged with radioiron, 8 "trans. assoc. amer. physic. 64:245, 1951. steinkamp, r., dubach, r. and moore, c.y. "studies in 9 iron transportation and metabolism," arch. int. med. 95:181, 1955. gorten, m.k. and bradley, j.e.: "the treatment of nutritional anemia in infancy and childhood with oral iron and ascorbic l0 acid,"j. pediatrics, 45: 1, 1954. mazur, a.: "role of ascorbic acid in the incorporation of plasma iron 11 into ferritin." an. n.y. acad. sci. 92:223-229, 1961. cox, e. v. et al.: "the anemia of scurvy," amer. j. 12 med. 42:220-227, 1967. berk, l. et al.: "observations on the etiologic relationship of achylia 13 gastrica to pernicious anemia, x," n. eng. j. med. 239:911-913, 1948. hall, b.e.: "studies on the 14 nature of the intrinsic factor of castle," brit. med. j. 2:585-589,1950. wallerstein, r.o. et al.: "observations on the etiologic relationship of achylia gastrica to pernicious anemia, xv" j. lab 15 & clin. med. 41 :363-375, 1953. castle, w.b.: "observations on the etiologic relationship of achylia 16 gastrica to pernicious anemia, 1," am. j. med. sc.178:748-764, 1929.

Package Label Principal Display Panel:

Package label.principal display panel nnodium hematogen 631 label


Comments/ Reviews:

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