FDA.reportPublic FDA data

NDC 0378-6613-85 - Amnesteem

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
0378-6613
Requested NDC
0378-6613-85
Package NDCs from labels
0378-6613-85, 0378-6613-93
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2026-08-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amnesteem - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2026-08-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-6613-85Amnesteem10 in 1 BLISTER PACKCAPSULE1023
0378-6613-93Amnesteem3 in 1 CARTONCAPSULE323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6613AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]22Current NDC, 2 package rows20250412_b2cb63c9-f825-4991-9a2c-6260f1bbcc2c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6613-85EA - Each0378-66138d3dc274-7cf2-409b-804b-ae1316867e6112025-05-14
0378-6613-93EA - Each0378-6613ab153841-4a49-482b-9c2a-c6785a7e08ee12025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOTRETINOINACTIVE INGREDIENTEH28UP18IFAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
ISOTRETINOINACTIVE MOIETYEH28UP18IFAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
SOYBEAN OILINACTIVE INGREDIENT241ATL177AAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7

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 2 of 126 · 2,519 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSShenzhen Leadtop E-commerce Co.,Ltd.558e8629-6a8d-198d-e063-6294a90ac5fc2026-08-19WarningsExact identifier
unii: 5138Q19F1X
Absorica LDISOTRETINOINSun Pharmaceutical Industries, Inc.3ef0cff8-19c1-4441-b780-fca6c7ee16152026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Smelling SaltAMMONIAShenzhen Jufeng Qisheng Technology Co., Ltd.44e1b2c1-f524-782c-e063-6394a90ad1e42026-08-18WarningsExact identifier
unii: 5138Q19F1X
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
AmnesteemISOTRETINOINMylan Pharmaceuticals Inc.b2cb63c9-f825-4991-9a2c-6260f1bbcc2c2026-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075945
ndc (package): 0378-6614-93
ndc (package): 0378-6611-93
ndc (package): 0378-6613-93
ndc (package): 0378-6614-85
ndc (package): 0378-6612-85
ndc (package): 0378-6613-85
ndc (package): 0378-6612-93
ndc (package): 0378-6611-85
ndc (product): 0378-6613
ndc (product): 0378-6612
ndc (product): 0378-6614
ndc (product): 0378-6611
ndc11 (package): 00378661385
rxcui: 404061
rxcui: 197844
rxcui: 197845
rxcui: 2711694
rxcui: 404064
rxcui: 404058
rxcui: 403930
rxcui: 197843
spl id: 4e5dc880-a474-43c1-b126-9cce9e6d066f
spl set id: b2cb63c9-f825-4991-9a2c-6260f1bbcc2c
unii: EH28UP18IF
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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