FDA.reportPublic FDA data

Abrotanum

Product NDC
63545-714
Requested package NDC
63545-714-04
11-digit product format
635450714
Labeler code
63545
Product ID
63545-714_2b4a1f65-5ba8-16e6-e063-6394a90afb58
Type
HUMAN OTC DRUG
Nonproprietary name
Abrotanum
Dosage form
PELLET
Route
ORAL
Labeler
Hahnemann Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-12-18
Substance
ARTEMISIA ABROTANUM FLOWERING TOP
Active strength
1 [hp_M]/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 packagepackage63545-71463545-714-04IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63545-71463545-714-04IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63545-71463545-714-04IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARTEMISIA ABROTANUM FLOWERING TOP1 [hp_M]/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
9a0036e9-0c43-6cef-e053-2995a90a7298Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
63545-714-012022-07-27ba0f9c33-5396-a910-e053-dadaa90a0b859a0036e9-0c43-6cef-e053-2995a90a7298
63545-714-022022-07-27ba0f9c33-5d72-a910-e053-dadaa90a0b859a0032c4-afd5-4eba-e053-2995a90ad301
63545-714-032022-07-27ba0f9c33-494a-a910-e053-dadaa90a0b859a007e04-eaf4-fc06-e053-2995a90a82d2
63545-714-042022-07-27ba0f9c33-34e0-a910-e053-dadaa90a0b859a00719d-eaf6-d8c3-e053-2995a90ac960
63545-714-012021-01-29ba0f9c33-5396-a910-e053-dadaa90a0b859a0036e9-0c43-6cef-e053-2995a90a7298
63545-714-022021-01-29ba0f9c33-5d72-a910-e053-dadaa90a0b859a0032c4-afd5-4eba-e053-2995a90ad301
63545-714-032021-01-29ba0f9c33-494a-a910-e053-dadaa90a0b859a007e04-eaf4-fc06-e053-2995a90a82d2
63545-714-042021-01-29ba0f9c33-34e0-a910-e053-dadaa90a0b859a00719d-eaf6-d8c3-e053-2995a90ac960

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63545-714-01Abrotanum200 in 1 VIAL, GLASSPELLET20011
63545-714-02Abrotanum500 in 1 VIAL, GLASSPELLET50011
63545-714-03Abrotanum3000 in 1 BOTTLE, GLASSPELLET300011
63545-714-04Abrotanum10000 in 1 BOTTLE, GLASSPELLET1000011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63545-714ABROTANUM PELLET [HAHNEMANN LABORATORIES, INC.]11Current NDC, Legacy NDC, 1 package rows20250112_9a007e04-eaf4-fc06-e053-2995a90a82d2.zip
63545-714ABROTANUM PELLET [HAHNEMANN LABORATORIES, INC.]11Current NDC, Legacy NDC, 1 package rows20250112_9a0032c4-afd5-4eba-e053-2995a90ad301.zip
63545-714ABROTANUM PELLET [HAHNEMANN LABORATORIES, INC.]11Current NDC, Legacy NDC, 1 package rows20250112_9a00719d-eaf6-d8c3-e053-2995a90ac960.zip
63545-714ABROTANUM PELLET [HAHNEMANN LABORATORIES, INC.]11Current NDC, Legacy NDC, 1 package rows20250112_9a0036e9-0c43-6cef-e053-2995a90a7298.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.9a0036e9-0c43-6cef-e053-2995a90a72982025-01-09Exact identifier
ndc (product): 63545-714
AbrotanumABROTANUMHahnemann Laboratories, Inc.9a007e04-eaf4-fc06-e053-2995a90a82d22025-01-09Exact identifier
ndc (product): 63545-714
AbrotanumABROTANUMHahnemann Laboratories, Inc.9a0032c4-afd5-4eba-e053-2995a90ad3012025-01-09Exact identifier
ndc (product): 63545-714
AbrotanumABROTANUMHahnemann Laboratories, Inc.9a00719d-eaf6-d8c3-e053-2995a90ac9602025-01-09Exact identifier
ndc (package): 63545-714-04
ndc (product): 63545-714
ndc11 (package): 63545071404

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63545-714-046354507140410000 PELLET in 1 BOTTLE, GLASS (63545-714-04) 10000 pellet2019-12-180000-00-00NoNoCurrent