FDA.reportPublic FDA data

Avedana Glycerin

Product NDC
43749-440
Requested package NDC
43749-440-00
11-digit product format
437490440
Labeler code
43749
Product ID
43749-440_e1c38f01-b50c-88ea-e053-2a95a90ac32a
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Unipack LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-09-18
Marketing end
0000-00-00
Substance
GLYCERIN
Active strength
2 g/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43749-44043749-440-00IInactivated by FDA2026-10-05

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
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage43749-44043749-440-00IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
43749-440-002020-10-269d75b9d0-9b20-f424-e053-dadaa90a57ceAvedana ® Glycerin Suppositories 100 count Drug Facts
43749-440-252020-10-169d75b9d0-a0a5-f424-e053-dadaa90a57ceAvedana ® Glycerin Suppositories Drug Facts
43749-440-002020-01-319d75b9d0-9b20-f424-e053-dadaa90a57ceAvedana ® Glycerin Suppositories 100 count Drug Facts
43749-440-252020-01-319d75b9d0-a0a5-f424-e053-dadaa90a57ceAvedana ® Glycerin Suppositories Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43749-440-00Avedana GlycerinLaxative100 in 1 JARSUPPOSITORY1008
43749-440-25Avedana GlycerinLaxative25 in 1 JARSUPPOSITORY257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43749-440-00EA - Each43749-440045153b5-d2f2-43eb-b0b1-e845b64a960012024-04-05
43749-440-25EA - Each43749-440da3fc0a5-d5c1-4024-bc84-6b9d7d03891c12024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXAVEDANA GLYCERIN LAXATIVE (GLYCERIN SUPPOSITORY) SUPPOSITORY [UNIPACK, INC.]1
GLYCERINACTIVE MOIETYPDC6A3C0OXAVEDANA GLYCERIN LAXATIVE (GLYCERIN SUPPOSITORY) SUPPOSITORY [UNIPACK, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IAVEDANA GLYCERIN LAXATIVE (GLYCERIN SUPPOSITORY) SUPPOSITORY [UNIPACK, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAVEDANA GLYCERIN LAXATIVE (GLYCERIN SUPPOSITORY) SUPPOSITORY [UNIPACK, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RAVEDANA GLYCERIN LAXATIVE (GLYCERIN SUPPOSITORY) SUPPOSITORY [UNIPACK, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43749-440AVEDANA GLYCERIN LAXATIVE (GLYCERIN) SUPPOSITORY [UNIPACK LLC]8Legacy NDC, 1 package rows20240105_4c1f7ab1-6274-4dd1-bbfc-869dec5797cf.zip
43749-440AVEDANA GLYCERIN LAXATIVE (GLYCERIN) SUPPOSITORY [UNIPACK LLC]7Legacy NDC, 1 package rows20240105_74b0dcab-cf76-44fc-83c5-c426d2a8b157.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104155glycerin 2 GM Rectal SuppositoryPSN4c1f7ab1-6274-4dd1-bbfc-869dec5797cf8
104155glycerin 2000 MG Rectal SuppositorySCD4c1f7ab1-6274-4dd1-bbfc-869dec5797cf8
104155glycerin 2 GM Rectal SuppositorySY4c1f7ab1-6274-4dd1-bbfc-869dec5797cf8
104155glycerin 2 GM Rectal SuppositoryPSN74b0dcab-cf76-44fc-83c5-c426d2a8b1577
104155glycerin 2000 MG Rectal SuppositorySCD74b0dcab-cf76-44fc-83c5-c426d2a8b1577
104155glycerin 2 GM Rectal SuppositorySY74b0dcab-cf76-44fc-83c5-c426d2a8b1577

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43749-440-0043749044000100 SUPPOSITORY in 1 JAR (43749-440-00) 100 suppository2017-09-170000-00-00NoNoCurrent