FDA.reportPublic FDA data

Altrenogest

Manufacturer
AMERICAN PHARMACEUTICAL INGREDIENTS LLC
Effective date
2013-10-31
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:49

Label at a glance#

ProductAltrenogest
Active ingredientALTRENOGEST
Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL – BULK PRODUCT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58597-7002-4Altrenogest25 g in 1 BOTTLEPOWDER251
58597-7002-5Altrenogest50 g in 1 BOTTLEPOWDER501
58597-7002-6Altrenogest100 g in 1 BOTTLEPOWDER1001
58597-7002-7Altrenogest500 g in 1 BOTTLEPOWDER5001
58597-7002-8Altrenogest1000 g in 1 BOTTLEPOWDER10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58597-7002ALTRENOGEST (ALTRENOGES) POWDER [AMERICAN PHARMACEUTICAL INGREDIENTS LLC]15 package rows20131101_d6dd6527-9442-4bd0-ac22-ff0627c6d91d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALTRENOGESTACTIVE INGREDIENT2U0X0JA2NB1
ALTRENOGESTACTIVE MOIETY2U0X0JA2NB1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58597-700258597-7002-4, 58597-7002-5, 58597-7002-6, 58597-7002-7, 58597-7002-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALTRENOGEST2U0X0JA2NBACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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