FDA.reportPublic FDA data

Ferralet 90

Product NDC
0178-0089
11-digit product format
001780089
Labeler code
0178
Product ID
0178-0089_47d48d1f-2aa3-6c05-e063-6294a90a0b21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mission Pharmacal Company
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-02-04
Substance
ASCORBIC ACID; CYANOCOBALAMIN; DOCUSATE SODIUM; FOLIC ACID; IRON
Active strength
120; 12; 50; 1; 90 mg/1; ug/1; mg/1; mg/1; mg/1
Pharmacologic classes
Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ferralet 90
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASCORBIC ACID120 mg/1
CYANOCOBALAMIN12 ug/1
DOCUSATE SODIUM50 mg/1
FOLIC ACID1 mg/1
IRON90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPQ6CK8PD0R, P6YC3EG204, F05Q2T2JA0, 935E97BOY8, E1UOL152H7
Rxcui836268, 836270

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0178-0089-902021-01-06C16284748780-19d75b9d0-490c-f424-e053-dadaa90a57ceFerralet ® 90 90 mg Dual-Iron Delivery
0178-0089-902020-01-31C16284748780-19d75b9d0-490c-f424-e053-dadaa90a57ceFerralet ® 90 90 mg Dual-Iron Delivery

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0089-90Ferralet 9090 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0089-90EA - Each0178-0089e3708453-ed7e-4df7-b053-15dc0479f0c512012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0089FERRALET 90 (IRON, FOLIC ACID, CYANOCOBALAMIN, ASCORBIC ACID, AND DOCUSATE SODIUM) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]7Current NDC, Legacy NDC, 1 package rows20240110_0be2918e-55b3-4c66-aba0-09099a1c7770.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836270ascorbic acid 120 MG / docusate sodium 50 MG / folic acid 1 MG / iron carbonyl 90 MG / vitamin B12 0.012 MG Oral Tablet [Ferralet 90]SBD0be2918e-55b3-4c66-aba0-09099a1c77708
836268ascorbic acid 120 MG / docusate sodium 50 MG / folic acid 1 MG / iron carbonyl 90 MG / vitamin B12 0.012 MG Oral TabletSCD0be2918e-55b3-4c66-aba0-09099a1c77708
836268cyanocobalamin 12 MCG / docusate sodium 50 MG / folic acid 1 MG / iron carbonyl 90 MG / vitamin C 120 MG Oral TabletSY0be2918e-55b3-4c66-aba0-09099a1c77708
836270Ferralet 90 Oral TabletSY0be2918e-55b3-4c66-aba0-09099a1c77708
836268vit-C 120 MG / DOSS sodium 50 MG / folate 1 MG / iron carbonyl 90 MG / vitamin B12 0.012 MG Oral TabletSY0be2918e-55b3-4c66-aba0-09099a1c77708
836270vit-C 120 MG / DOSS sodium 50 MG / folate 1 MG / iron carbonyl 90 MG / vitamin B12 0.012 MG Oral Tablet [Ferralet 90]SY0be2918e-55b3-4c66-aba0-09099a1c77708
836268vitamin C 120 MG / DOSS sodium 50 MG / folate 1 MG / iron carbonyl 90 MG / vitamin B12 0.012 MG Oral TabletSY0be2918e-55b3-4c66-aba0-09099a1c77708
836270vitamin C 120 MG / DOSS sodium 50 MG / folate 1 MG / iron carbonyl 90 MG / vitamin B12 0.012 MG Oral Tablet [Ferralet 90]SY0be2918e-55b3-4c66-aba0-09099a1c77708

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0178-0089-900017800899090 TABLET, FILM COATED in 1 BOTTLE (0178-0089-90) 2010-06-230000-00-00NoNoCurrent