FDA.reportPublic FDA data

HEMATOGEN

Product NDC
63044-631
Requested package NDC
63044-631-19
11-digit product format
630440631
Labeler code
63044
Product ID
63044-631_bade8948-0105-48cf-944e-fcaf823ce77f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FERROUS FUMARATE, ASCORBIC ACID, INTRINSIC FACTOR , CYANOCOBALAMIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Nnodum Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2007-05-10
Marketing end
0000-00-00
Substance
FERROUS FUMARATE; ASCORBIC ACID; INTRINSIC FACTOR; CYANOCOBALAMIN
Active strength
66 mg/1; mg/1; mg/1; ug/1
Pharmacologic classes
Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B 12 [CS],Vitamin B12 [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63044-63163044-631-19IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63044-63163044-631-19IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63044-63163044-631-19IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63044-63163044-631-19IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-12-29Hematogen Softgel capsule
2023-07-28Hematogen Softgel capsule
2021-12-23Hematogen Softgel capsule
2019-11-27Hematogen Softgel capsule

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63044-631-19HEMATOGEN1 in 1 BLISTER PACKCAPSULE116
63044-631-19HEMATOGEN100 in 1 BOXCAPSULE10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63044-631-19EA - Each63044-631cec3f9aa-2e5e-4ab5-b3a2-68966f6530e812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0RHEMATOGEN (FERROUS FUMARATE, ASCORBIC ACID, INTRINSIC FACTOR , CYANOCOBALAMIN ) CAPSULE [NNODUM PHARMACEUTICALS]13
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204HEMATOGEN (FERROUS FUMARATE, ASCORBIC ACID, INTRINSIC FACTOR , CYANOCOBALAMIN ) CAPSULE [NNODUM PHARMACEUTICALS]13
FERROUS FUMARATEACTIVE INGREDIENTR5L488RY0QHEMATOGEN (FERROUS FUMARATE, ASCORBIC ACID, INTRINSIC FACTOR , CYANOCOBALAMIN ) CAPSULE [NNODUM PHARMACEUTICALS]13
INTRINSIC FACTORACTIVE INGREDIENT70BT6OQT2QHEMATOGEN (FERROUS FUMARATE, ASCORBIC ACID, INTRINSIC FACTOR , CYANOCOBALAMIN ) CAPSULE [NNODUM PHARMACEUTICALS]13
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0RHEMATOGEN (FERROUS FUMARATE, ASCORBIC ACID, INTRINSIC FACTOR , CYANOCOBALAMIN ) CAPSULE [NNODUM PHARMACEUTICALS]13
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204HEMATOGEN (FERROUS FUMARATE, ASCORBIC ACID, INTRINSIC FACTOR , CYANOCOBALAMIN ) CAPSULE [NNODUM PHARMACEUTICALS]13
FERROUS CATIONACTIVE MOIETYGW89581OWRHEMATOGEN (FERROUS FUMARATE, ASCORBIC ACID, INTRINSIC FACTOR , CYANOCOBALAMIN ) CAPSULE [NNODUM PHARMACEUTICALS]13
INTRINSIC FACTORACTIVE MOIETY70BT6OQT2QHEMATOGEN (FERROUS FUMARATE, ASCORBIC ACID, INTRINSIC FACTOR , CYANOCOBALAMIN ) CAPSULE [NNODUM PHARMACEUTICALS]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63044-631HEMATOGEN (FERROUS FUMARATE, ASCORBIC ACID, INTRINSIC FACTOR , CYANOCOBALAMIN ) CAPSULE [NNODUM PHARMACEUTICALS]16Legacy NDC, 2 package rows20241230_c36cb9d3-f0a3-4d34-92f2-8ab281b26b7d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63044-631-1963044063119100 BLISTER PACK in 1 BOX (63044-631-19) > 1 CAPSULE in 1 BLISTER PACK100 blister pack2007-05-100000-00-00NoNoCurrent