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Hematogen Ferrous Fumarate, Ascorbic Acid, Intrinsic Factor , Cyanocobalamin 250; 10; 66; 100 mg; ug; mg; mg Capsule, 100-count — NDC 63044-0631-19 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hematogen Ferrous Fumarate, Ascorbic Acid, Intrinsic Factor , Cyanocobalamin 250; 10; 66; 100 mg; ug; mg; mg Capsule, 100-count — NDC 63044-631-19 (Billing 63044-0631-19)

by Nnodum Pharmaceuticals · 100 BLISTER PACK in 1 BOX / 1 CAPSULE in 1 BLISTER PACK

This is a package of 100 capsules of Hematogen Ferrous Fumarate, Ascorbic Acid, Intrinsic Factor , Cyanocobalamin 250; 10; 66; 100 mg; ug; mg; mg Capsule from Nnodum Pharmaceuticals, no longer marketed, no longer in the FDA NDC Directory. It is this product's only package size.

NDC 63044-0631-19
🏷️ FDA NDC (as labeled) 63044-631-19 billing pads the product segment with a zero
Rx only Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 63044-631-19 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63044 labeler · 631 product · 19 package
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 6304463119 8
FDA record last changed
Jul 14, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63044-631-19
Product NDC 63044-631
11-digit billing NDC 63044063119
NCPDP billing unit EA — each (per item)
SPL Set ID c36cb9d3-f0a3-4d34-92f2-8ab281b26b7d
Established class (EPC) Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2025)
Route ORAL
Dosage form CAPSULE
Substance ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; INTRINSIC FACTOR

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 062970
GCN 98730
HICL code 000657
Ingredient (HICL) Ferrous Fum/Vit C/B12/Stomc
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C3
Therapeutic class — intermediate (HIC2) Minerals
HIC3 code C3B
Therapeutic class — specific (HIC3) Iron Replacement
AHFS code 20:04.04.00
AHFS class Iron Preparations
FDB label name HEMATOGEN SOFTGEL
FDB brand name Hematogen
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 062970
  • GCN: 98730
  • HICL (First Databank): 000657
  • AHFS class code: 20:04.04.00
Why two NDCs? The FDA registers this code as 63044-631-19 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63044-0631-19. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name HEMATOGEN SOFTGEL Ingredient Ferrous Fum/Vit C/B12/Stomc

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63044-0631-19 You're viewing this Main listing 100 BLISTER PACK in 1 BOX / 1 CAPSULE in 1 BLISTER PACK 2007-05-10 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hematogen 250; 10; 66; 100 mg/1; ug/1; mg/1; mgthis 63044-0631-19 Nnodum 100 capsules — — Discontinued —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Red
ShapeOval
Imprintziks;631
Size4 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNnodum Pharmaceuticals
Labeler code63044
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Nnodum Pharmaceuticals labeler code 63044

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

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 12 words ▾

DOSAGE AND ADMINISTRATION: Usual adult dose is 1 soft gelatin capsule daily.

⛔ Contraindications 50 words ▾

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 27 words ▾

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 ~2 min read ▾

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 / Storage and Handling ~2 min read ▾

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 8 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nnodium Hematogen 631 Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application No longer marketed (per FDA listing data)

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Nnodum Pharmaceuticals is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63044-0030-60 · Nnodum 63044-0635-10 · Nnodum →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.