HELLEBORUS NIGER

Product NDC
15631-0221
11-digit product format
156310221
Labeler code
15631
Product ID
15631-0221_a14729bb-05ca-9209-e053-2a95a90adea1
Type
HUMAN OTC DRUG
Nonproprietary name
HELLEBORUS NIGER
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
HELLEBORUS NIGER ROOT
Active strength
3 [hp_X]/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15631-0221-02022-01-28C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-12022-01-28C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-22022-01-28C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-32022-01-28C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-42022-01-28C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-52022-01-28C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-02020-03-20C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-12020-03-20C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-22020-03-20C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-32020-03-20C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-42020-03-20C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-52020-03-20C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-02020-01-31C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-12020-01-31C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-22020-01-31C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-32020-01-31C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-42020-01-31C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e
15631-0221-52020-01-31C16284748780-19d75b9d0-4e31-f424-e053-dadaa90a57cea21b3d98-2978-42cb-b264-65758561d85e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0221-0HELLEBORUS NIGER100 in 1 PACKAGEPELLET1002
15631-0221-1HELLEBORUS NIGER200 in 1 PACKAGEPELLET2002
15631-0221-2HELLEBORUS NIGER400 in 1 PACKAGEPELLET4002
15631-0221-3HELLEBORUS NIGER750 in 1 PACKAGEPELLET7502
15631-0221-4HELLEBORUS NIGER2500 in 1 PACKAGEPELLET25002
15631-0221-5HELLEBORUS NIGER12500 in 1 PACKAGEPELLET125002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HELLEBORUS NIGER ROOTACTIVE INGREDIENT608DGJ6815HELLEBORUS NIGER PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
HELLEBORUS NIGER ROOTACTIVE MOIETY608DGJ6815HELLEBORUS NIGER PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554HELLEBORUS NIGER PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0221HELLEBORUS NIGER PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2Legacy NDC, 6 package rows20200320_a21b3d98-2978-42cb-b264-65758561d85e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15631-0221-015631022100100 PELLET in 1 PACKAGE (15631-0221-0) 100 pellet2018-01-010000-00-00NoNoCurrent
15631-0221-115631022101200 PELLET in 1 PACKAGE (15631-0221-1) 200 pellet2018-01-010000-00-00NoNoCurrent
15631-0221-215631022102400 PELLET in 1 PACKAGE (15631-0221-2) 400 pellet2018-01-010000-00-00NoNoCurrent
15631-0221-315631022103750 PELLET in 1 PACKAGE (15631-0221-3) 750 pellet2018-01-010000-00-00NoNoCurrent
15631-0221-4156310221042500 PELLET in 1 PACKAGE (15631-0221-4) 2500 pellet2018-01-010000-00-00NoNoCurrent
15631-0221-51563102210512500 PELLET in 1 PACKAGE (15631-0221-5) 12500 pellet2018-01-010000-00-00NoNoCurrent