NDC 0832-8301-89 - Isotretinoin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0832-8301
Requested NDC
0832-8301-89
Package NDCs from labels
0832-8301-89, 0832-8301-30
Manufacturer
Upsher-Smith Laboratories, LLC | Douglas Manufacturing Limited
Effective date
2026-02-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isotretinoin - Upsher-Smith Laboratories, LLC | Douglas Manufacturing LimitedUpsher-Smith Laboratories, LLC | Douglas Manufacturing Limited2026-02-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-8301-30Isotretinoin3 in 1 BOXCAPSULE, LIQUID FILLED33
0832-8301-89Isotretinoin10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-8301ISOTRETINOIN CAPSULE, LIQUID FILLED [UPSHER-SMITH LABORATORIES, LLC]1Current NDC, 2 package rows20230610_c369e1c3-90c5-4768-9741-56c62253a2c4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-8301-30EA - Each0832-83016c5461fa-765c-4e1a-8c78-4f4e8c8cdc2712023-07-06
0832-8301-89EA - Each0832-830124b5cfbe-3da0-4e76-a642-75425637d88312023-08-08

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 63 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Mahogany TeakwoodALCOHOLBath & Body Works, Inc.1bba8dfa-947c-1ee2-e063-6294a90ae52a2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Strawberry Pound CakeALCOHOLBath & Body Works, Inc.1bba8dfa-947f-1ee2-e063-6294a90ae52a2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel A Thousand WishesALCOHOLBath & Body Works, Inc.29a539bb-42e3-dc73-e063-6394a90a5fe92026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Peach BelliniALCOHOLBath & Body Works, Inc.2b1124a3-9b14-07b6-e063-6394a90a49732026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Watermelon LemonadeALCOHOLBath & Body Works, Inc.38e1bd3f-8e6e-7b68-e063-6394a90a82742026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sunshine and LemonsALCOHOLBath & Body Works, Inc.1bba8dfa-9481-1ee2-e063-6294a90ae52a2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Midnight Blue CitrusALCOHOLBath & Body Works, Inc.2b116b79-fe71-325a-e063-6394a90a045b2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Warm Vanilla SugarALCOHOLBath & Body Works, Inc.38d6f6a0-52bf-df77-e063-6394a90a44642026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Crystal Blue CoastALCOHOLBath & Body Works, Inc.38e1480e-d217-7b66-e063-6394a90abfe52026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Raspberry TangerineALCOHOLBath & Body Works, Inc.38e1cc04-7905-74e4-e063-6394a90a7b4c2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Backyard HoneysuckleALCOHOLBath & Body Works, Inc.38e1480e-d21c-7b66-e063-6394a90abfe52026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh RainfallALCOHOLBath & Body Works, Inc.38e1480e-d21d-7b66-e063-6394a90abfe52026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Raspberries and Whipped VanillaALCOHOLBath & Body Works, Inc.38e1cef4-4814-745c-e063-6394a90aebf02026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fiji White SandsALCOHOLBath & Body Works, Inc.38e1c1d6-6505-4066-e063-6294a90ad3f42026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sweetest SongALCOHOLBath & Body Works, Inc.38e1d907-75d7-3906-e063-6294a90a2ed72026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Endless WeekendALCOHOLBath & Body Works, Inc.38e15918-9ee2-4061-e063-6294a90a881c2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pina Colada SwirlALCOHOLBath & Body Works, Inc.38e1e122-2087-90fa-e063-6394a90ab6252026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Eucalyptus and SpearmintALCOHOLBath & Body Works, Inc.38e1f8da-2003-80ba-e063-6394a90a2d1d2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sweet Orange and AgaveALCOHOLBath & Body Works, Inc.38e1d8fc-6f10-49d6-e063-6294a90a25ab2026-03-09WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Book LoftALCOHOLBath & Body Works, Inc.38e1d8fc-6f11-49d6-e063-6294a90a25ab2026-03-09WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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