FDA.reportPublic FDA data

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 6 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IsotretinoinISOTRETINOINAmneal Pharmaceuticals LLCc2917c3d-3499-48a0-ba53-120cb979195d2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
InstantFoam Complete PUREALCOHOLSC Johnson Professional USA Inc.398ca23c-7202-4670-be14-9829675f71742026-08-27WarningsExact identifier
unii: 3K9958V90M
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Stone Hand SanitizerISOPROPYL ALCOHOLhandetizer, LLC.59f821e0-b129-5c39-e063-6294a90a47a02026-08-26WarningsExact identifier
unii: ND2M416302
Scentsational Square Hand SanitizerHAND SANITIZERRaining Rose, Inc.59f9bacf-80dc-3468-e063-6294a90a0ae12026-08-26WarningsExact identifier
unii: 3K9958V90M
Curad Alcohol Sterile, ThickISOPROPYL ALCOHOLMedline Industries, LPb769898e-a73f-4323-af15-bee8dbe455b62026-08-25WarningsExact identifier
unii: ND2M416302
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
SpectrumETHYL ALCOHOLMedline Industries, LP428b1cb9-7db8-3141-e054-00144ff8d46c2026-08-25WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
unii: 3K9958V90M
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Smelling SaltsAMMONIAShenzhen Finona Information Technology Co., Ltd3874ec89-0f1d-87b9-e063-6394a90a300a2026-08-24WarningsExact identifier
unii: 5138Q19F1X
Ethyl alcohol 62%ETHYL ALCOHOL 62%UpLift Brands, LLC59cea08d-299a-2f50-e063-6394a90a6e142026-08-24Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Inc23d0dc62-28d6-4d1f-a7d5-4b14f5c9fb1e2026-08-24WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer STRAWBERRY SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO9b0101ef-54cf-466e-8c27-4429d5cf4d172026-08-21WarningsExact identifier
unii: 3K9958V90M
hand sanitizer- light blue 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a96f0-33fe-40aa-e063-6394a90aeacb2026-08-21WarningsExact identifier
unii: 3K9958V90M
hand sanitizer- light green 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a165a-90ff-e00c-e063-6394a90a33512026-08-21WarningsExact identifier
unii: 3K9958V90M
hand sanitizer- light purple 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598b7bb8-0d2e-a66f-e063-6294a90a45b82026-08-21WarningsExact identifier
unii: 3K9958V90M
Hand sanitizer disinfectionHAND SANITIZER DISINFECTIONGuangzhou Huanmei Cosmetics Co., Ltd.598bf234-d2da-4e59-e063-6294a90a67e42026-08-21WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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