FDA.reportPublic FDA data

Abrotanum

Product NDC
63545-713
Requested package NDC
63545-713-04
11-digit product format
635450713
Labeler code
63545
Product ID
63545-713_2b4a1f65-5ba7-16e6-e063-6394a90afb58
Type
HUMAN OTC DRUG
Nonproprietary name
Abrotanum
Dosage form
PELLET
Route
ORAL
Labeler
Hahnemann Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-12-17
Substance
ARTEMISIA ABROTANUM FLOWERING TOP
Active strength
500 [hp_C]/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 · 3 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
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63545-71363545-713-04IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63545-71363545-713-04IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63545-71363545-713-04IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…

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
Abrotanum
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARTEMISIA ABROTANUM FLOWERING TOP500 [hp_C]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QG07G580U0Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
99ef26d5-de23-1cae-e053-2995a90a3ffdAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
63545-713-022022-07-27ba0f9c33-3ee2-a910-e053-dadaa90a0b8599eefa29-21f2-7fb9-e053-2995a90afb60
63545-713-032022-07-27ba0f9c33-5d36-a910-e053-dadaa90a0b8599ef0e70-5722-da4a-e053-2995a90aabc0
63545-713-042022-07-27ba0f9c33-206c-a910-e053-dadaa90a0b8599ef26d5-de23-1cae-e053-2995a90a3ffd
63545-713-012022-07-26ba0f9c33-3edf-a910-e053-dadaa90a0b8599eeeff1-75db-5226-e053-2995a90a42ab
63545-713-012021-01-29ba0f9c33-3edf-a910-e053-dadaa90a0b8599eeeff1-75db-5226-e053-2995a90a42ab
63545-713-022021-01-29ba0f9c33-3ee2-a910-e053-dadaa90a0b8599eefa29-21f2-7fb9-e053-2995a90afb60
63545-713-032021-01-29ba0f9c33-5d36-a910-e053-dadaa90a0b8599ef0e70-5722-da4a-e053-2995a90aabc0
63545-713-042021-01-29ba0f9c33-206c-a910-e053-dadaa90a0b8599ef26d5-de23-1cae-e053-2995a90a3ffd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63545-713-03Abrotanum3000 in 1 BOTTLE, GLASSPELLET300010
63545-713-04Abrotanum10000 in 1 BOTTLE, GLASSPELLET1000010
63545-713-01Abrotanum200 in 1 VIAL, GLASSPELLET2009
63545-713-02Abrotanum500 in 1 VIAL, GLASSPELLET5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63545-713ABROTANUM PELLET [HAHNEMANN LABORATORIES, INC.]10Current NDC, Legacy NDC, 1 package rows20250112_99ef26d5-de23-1cae-e053-2995a90a3ffd.zip
63545-713ABROTANUM PELLET [HAHNEMANN LABORATORIES, INC.]10Current NDC, Legacy NDC, 1 package rows20250112_99ef0e70-5722-da4a-e053-2995a90aabc0.zip
63545-713ABROTANUM PELLET [HAHNEMANN LABORATORIES, INC.]9Current NDC, Legacy NDC, 1 package rows20250112_99eeeff1-75db-5226-e053-2995a90a42ab.zip
63545-713ABROTANUM PELLET [HAHNEMANN LABORATORIES, INC.]9Current NDC, Legacy NDC, 1 package rows20250112_99eefa29-21f2-7fb9-e053-2995a90afb60.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AbrotanumABROTANUMHahnemann Laboratories, Inc.99ef26d5-de23-1cae-e053-2995a90a3ffd2025-01-09Exact identifier
ndc (package): 63545-713-04
ndc (product): 63545-713
ndc11 (package): 63545071304
AbrotanumABROTANUMHahnemann Laboratories, Inc.99eefa29-21f2-7fb9-e053-2995a90afb602025-01-09Exact identifier
ndc (product): 63545-713
AbrotanumABROTANUMHahnemann Laboratories, Inc.99eeeff1-75db-5226-e053-2995a90a42ab2025-01-09Exact identifier
ndc (product): 63545-713
AbrotanumABROTANUMHahnemann Laboratories, Inc.99ef0e70-5722-da4a-e053-2995a90aabc02025-01-09Exact identifier
ndc (product): 63545-713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63545-713-046354507130410000 PELLET in 1 BOTTLE, GLASS (63545-713-04) 10000 pellet2019-12-170000-00-00NoNoCurrent