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 60 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-BacterialHandSpray Fresh RainfallALCOHOLBath & Body Works, Inc.463c1d31-a1be-e13c-e063-6294a90acacd2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Champagne Apple and HoneyALCOHOLBath & Body Works, Inc.463d3fc9-24d8-c2dc-e063-6294a90ab6bc2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Cinnamon Caramel SwirlALCOHOLBath & Body Works, Inc.463c4497-4aa7-032a-e063-6394a90a192a2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Winter Citrus WreathALCOHOLBath & Body Works, Inc.463c61c1-d752-88e2-e063-6294a90a9d172026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Marshmallow Pumpkin LatteALCOHOLBath & Body Works, Inc.463d408a-be41-2e5e-e063-6394a90a9ee62026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Winter Candy AppleALCOHOLBath & Body Works, Inc.4513447b-b36e-d2b6-e063-6394a90ae4f92026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne Apple and HoneyALCOHOLBath & Body Works, Inc.4650ac33-8d90-a5e7-e063-6294a90a18ed2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Lavender BergamotALCOHOLBath & Body Works, Inc.463d04c8-4df0-d3e5-e063-6394a90a0ff22026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Touch of GoldALCOHOLBath & Body Works, Inc.4650bdad-a4ad-cb5e-e063-6394a90ab2402026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh BalsamALCOHOLBath & Body Works, Inc.468c94df-7cf9-780f-e063-6294a90aa50f2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Beautiful DayALCOHOLBath & Body Works, Inc.463cb528-a54a-fc36-e063-6294a90a903d2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Gingerbread BakeryALCOHOLBath & Body Works, Inc.463f0966-c7a7-2bcb-e063-6394a90a26112026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Pineapple MangoALCOHOLBath & Body Works, Inc.463fc682-c8e4-17c7-e063-6294a90a21e62026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Japanese Cherry BlossomALCOHOLBath & Body Works, Inc.468c8e7a-95bb-6ad0-e063-6294a90a7ce92026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Blackberries and BasilALCOHOLBath & Body Works, Inc.463d31cc-a5b9-19cf-e063-6394a90af6af2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Bright Christmas MorningALCOHOLBath & Body Works, Inc.463eeded-9977-abac-e063-6294a90a4a742026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Book LoftALCOHOLBath & Body Works, Inc.4650ab55-8ce6-a5e1-e063-6294a90a79bf2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pure WonderALCOHOLBath & Body Works, Inc.468c90d7-3b9c-1641-e063-6394a90a928c2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Tree FarmALCOHOLBath & Body Works, Inc.463f1c97-cbbe-4735-e063-6394a90a3b5a2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Cucumber MelonALCOHOLBath & Body Works, Inc.463fa1ef-d40c-d818-e063-6294a90a5e612026-03-10WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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