Quflora FE Pediatric Drops

Product NDC
15370-102
11-digit product format
153700102
Labeler code
15370
Product ID
15370-102_a843f709-c7ea-456b-8bdc-48901d1fd2d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PANTOTHENIC ACID, PYRIDOXINE HYDROCHLORIDE, BIOTIN, LEVOMEFOLATE GLUCOSAMINE, CYANOCOBALAMIN, FERROUS SULFATE, and SODIUM FLUORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Carwin Pharmaceutical Associates, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-04-21
Marketing end
0000-00-00
Substance
VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; BIOTIN; LEVOMEFOLATE GLUCOSAMINE; CYANOCOBALAMIN; FERROUS SULFATE; SODIUM FLUORIDE
Active strength
1500 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; ug/mL; mg/mL; mg/mL
Pharmacologic classes
Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15370-102-502024-01-30C16284748780-11030e365-6fcf-111a-e063-dadaa90a10e2Quflora ® FE Pediatric Liquid Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15370-102-50Quflora FE Pediatric Drops1 in 1 CARTONLIQUID11
15370-102-50Quflora FE Pediatric Drops50 mL in 1 BOTTLE, DROPPERLIQUID501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15370-102-50ML - Milliliter15370-102ec18d3a2-0482-49de-9af0-1ab464a772b112017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15370-102QUFLORA FE PEDIATRIC DROPS (VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PANTOTHENIC ACID, PYRIDOXINE HYDROCHLORIDE, BIOTIN, LEVOMEFOLATE GLUCOSAMINE, CYANOCOBALAMIN, FERROUS SULFATE, AND SODIUM FLUORIDE) LIQUID [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]1Legacy NDC, 2 package rows20170422_feb95882-69f1-4f30-91aa-505f45f3ab3f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
15370-102-50153700102501 BOTTLE, DROPPER in 1 CARTON (15370-102-50) > 50 mL in 1 BOTTLE, DROPPER2017-04-210000-00-00NoNoCurrent