LEDUM PALUSTRE

Product NDC
15631-0272
Requested package NDC
15631-0272-0
11-digit product format
156310272
Labeler code
15631
Product ID
15631-0272_caa10608-92ac-34d9-e053-2a95a90af66a
Type
HUMAN OTC DRUG
Nonproprietary name
LEDUM PALUSTRE
Dosage form
PELLET
Route
ORAL
Labeler
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-09-07
Substance
LEDUM PALUSTRE TWIG
Active strength
1 [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage15631-027215631-0272-0EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
LEDUM PALUSTRE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEDUM PALUSTRE TWIG1 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
877L01IZ0PInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c1ebaf2-752f-4692-bc8c-f9a4f5f7c5a7Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0272-0LEDUM PALUSTRE100 in 1 VIAL, SINGLE-DOSEPELLET1004
15631-0272-1LEDUM PALUSTRE200 in 1 PACKAGEPELLET2004
15631-0272-2LEDUM PALUSTRE400 in 1 PACKAGEPELLET4004
15631-0272-3LEDUM PALUSTRE750 in 1 PACKAGEPELLET7504
15631-0272-4LEDUM PALUSTRE2500 in 1 PACKAGEPELLET25004
15631-0272-5LEDUM PALUSTRE12500 in 1 PACKAGEPELLET125004
15631-0272-6LEDUM PALUSTRE500 in 1 PACKAGEPELLET5004
15631-0272-7LEDUM PALUSTRE1000 in 1 PACKAGEPELLET10004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0PLEDUM PALUSTRE PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0PLEDUM PALUSTRE PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2
SUCROSEINACTIVE INGREDIENTC151H8M554LEDUM PALUSTRE PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0272LEDUM PALUSTRE PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]4Current NDC, Legacy NDC, 8 package rows20210903_5c1ebaf2-752f-4692-bc8c-f9a4f5f7c5a7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEDUM PALUSTRELEDUM PALUSTRERxhomeo Private Limited d.b.a. Rxhomeo, Inc5c1ebaf2-752f-4692-bc8c-f9a4f5f7c5a72021-09-02WarningsExact identifier
ndc (package): 15631-0272-0
ndc (product): 15631-0272
ndc11 (package): 15631027200

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15631-0272-015631027200100 PELLET in 1 VIAL, SINGLE-DOSE (15631-0272-0) 100 pellet2018-01-010000-00-00NoNoCurrent