FDA.reportPublic FDA data

Hematogen FA

Product NDC
63044-632
11-digit product format
630440632
Labeler code
63044
Product ID
63044-632_e6af69e7-db25-414d-9121-bbafd0fdd8b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Nnodum Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2005-01-01
Marketing end
0000-00-00
Substance
FERROUS FUMARATE; ASCORBIC ACID; FOLIC ACID; 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63044-632IInactivated by FDA2026-10-15
excluded packagepackage63044-63263044-632-17IInactivated by FDA2026-10-15

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63044-632-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63044-632-179bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63044-632-17110d247fa046…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
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63044-632-17Hematogen FA10 in 1 BOXCAPSULE109
63044-632-17Hematogen FA10 in 1 BLISTER PACKCAPSULE109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63044-632-17EA - Each63044-63273cd995c-ff6d-44b4-94d1-83aa98aef8ae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0RHEMATOGEN FA (FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN) CAPSULE [NNODUM PHARMACEUTICALS]6
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204HEMATOGEN FA (FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN) CAPSULE [NNODUM PHARMACEUTICALS]6
FERROUS FUMARATEACTIVE INGREDIENTR5L488RY0QHEMATOGEN FA (FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN) CAPSULE [NNODUM PHARMACEUTICALS]6
FOLIC ACIDACTIVE INGREDIENT935E97BOY8HEMATOGEN FA (FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN) CAPSULE [NNODUM PHARMACEUTICALS]6
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0RHEMATOGEN FA (FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN) CAPSULE [NNODUM PHARMACEUTICALS]6
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204HEMATOGEN FA (FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN) CAPSULE [NNODUM PHARMACEUTICALS]6
FERROUS CATIONACTIVE MOIETYGW89581OWRHEMATOGEN FA (FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN) CAPSULE [NNODUM PHARMACEUTICALS]6
FOLIC ACIDACTIVE MOIETY935E97BOY8HEMATOGEN FA (FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN) CAPSULE [NNODUM PHARMACEUTICALS]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63044-632HEMATOGEN FA (FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN) CAPSULE [NNODUM PHARMACEUTICALS]9Legacy NDC, 2 package rows20241230_fa1db7ce-a733-4036-aa4b-c4aec29829c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999749ascorbic acid 250 MG / ferrous fumarate 200 MG / folic acid 1 MG / vitamin B12 0.01 MG Oral Capsule [Hematogen]SBDfa1db7ce-a733-4036-aa4b-c4aec29829c19
348622ascorbic acid 250 MG / ferrous fumarate 200 MG / folic acid 1 MG / vitamin B12 0.01 MG Oral CapsuleSCDfa1db7ce-a733-4036-aa4b-c4aec29829c19
348622ascorbic acid 250 MG / cyanocobalamin 10 MCG / ferrous fumarate 200 MG / folic acid 1 MG Oral CapsuleSYfa1db7ce-a733-4036-aa4b-c4aec29829c19
999749Hematogen FA (ascorbic acid 250 MG / ferrous fumarate 200 MG / folic acid 1 MG / vitamin B 12 0.01 MG) Oral CapsuleSYfa1db7ce-a733-4036-aa4b-c4aec29829c19
348622vit-C 250 MG / ferrous fumarate 200 MG / folate 1 MG / vitamin B12 0.01 MG Oral CapsuleSYfa1db7ce-a733-4036-aa4b-c4aec29829c19
999749vit-C 250 MG / ferrous fumarate 200 MG / folate 1 MG / vitamin B12 0.01 MG Oral Capsule [Hematogen]SYfa1db7ce-a733-4036-aa4b-c4aec29829c19
348622vitamin C 250 MG / ferrous fumarate 200 MG / folate 1 MG / vitamin B12 0.01 MG Oral CapsuleSYfa1db7ce-a733-4036-aa4b-c4aec29829c19
999749vitamin C 250 MG / ferrous fumarate 200 MG / folate 1 MG / vitamin B12 0.01 MG Oral Capsule [Hematogen]SYfa1db7ce-a733-4036-aa4b-c4aec29829c19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63044-632-176304406321710 BLISTER PACK in 1 BOX (63044-632-17) > 10 CAPSULE in 1 BLISTER PACK10 blister pack2005-01-010000-00-00NoNoCurrent