UREA

Product NDC
15631-0449
11-digit product format
156310449
Labeler code
15631
Product ID
15631-0449_a1d2fcc9-cfc2-7d66-e053-2995a90a4195
Type
HUMAN OTC DRUG
Nonproprietary name
UREA
Dosage form
PELLET
Route
ORAL
Labeler
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-10-31
Marketing end
0000-00-00
Substance
UREA
Active strength
1 [hp_X]/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15631-0449-02022-01-28C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-12022-01-28C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-22022-01-28C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-32022-01-28C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-42022-01-28C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-52022-01-28C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-02020-03-27C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-12020-03-27C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-22020-03-27C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-32020-03-27C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-42020-03-27C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-52020-03-27C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-02020-01-31C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-12020-01-31C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-22020-01-31C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-32020-01-31C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-42020-01-31C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50
15631-0449-52020-01-31C16284748780-19d75b9cf-f6fb-f424-e053-dadaa90a57ce139e1c60-335f-41a0-81c6-81e17d7d7b50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0449-0UREA100 in 1 VIAL, SINGLE-DOSEPELLET1002
15631-0449-1UREA200 in 1 PACKAGEPELLET2002
15631-0449-2UREA400 in 1 PACKAGEPELLET4002
15631-0449-3UREA750 in 1 PACKAGEPELLET7502
15631-0449-4UREA2500 in 1 PACKAGEPELLET25002
15631-0449-5UREA12500 in 1 PACKAGEPELLET125002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UREAACTIVE INGREDIENT8W8T17847WUREA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
UREAACTIVE MOIETY8W8T17847WUREA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554UREA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0449UREA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2Legacy NDC, 6 package rows20200330_139e1c60-335f-41a0-81c6-81e17d7d7b50.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15631-0449-015631044900100 PELLET in 1 VIAL, SINGLE-DOSE (15631-0449-0) 100 pellet2018-01-010000-00-00NoNoCurrent
15631-0449-115631044901200 PELLET in 1 PACKAGE (15631-0449-1) 200 pellet2018-01-010000-00-00NoNoCurrent
15631-0449-215631044902400 PELLET in 1 PACKAGE (15631-0449-2) 400 pellet2018-01-010000-00-00NoNoCurrent
15631-0449-315631044903750 PELLET in 1 PACKAGE (15631-0449-3) 750 pellet2018-01-010000-00-00NoNoCurrent
15631-0449-4156310449042500 PELLET in 1 PACKAGE (15631-0449-4) 2500 pellet2018-01-010000-00-00NoNoCurrent
15631-0449-51563104490512500 PELLET in 1 PACKAGE (15631-0449-5) 12500 pellet2018-01-010000-00-00NoNoCurrent