FDA.reportPublic FDA data

NDC 68084-697-11 - BuPROPion Hydrochloride

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
68084-697
Requested NDC
68084-697-11
Package NDCs from labels
68084-697-11, 68084-697-01
Manufacturer
American Health Packaging
Effective date
2026-06-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BuPROPion Hydrochloride - American Health PackagingAmerican Health Packaging2026-06-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-697-01BuPROPion Hydrochloride100 in 1 BOX, UNIT-DOSETABLET, FILM COATED, EXTENDED RE10011
68084-697-11BuPROPion Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-697BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20241027_1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-697-01EA - Each68084-69757707c66-e391-4fd1-8951-ee5c7a47b57412015-05-05
68084-697-11EA - Each68084-697d4e33178-1ecd-4899-a5d8-aac95c2ec2ba12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3

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 5 of 142 · 2,840 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDELupin Pharmaceuticals, Inc.1af14d2e-c64d-44b7-a402-8869e8e306612026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEA-S Medication Solutions9aa3753f-1a0e-4faa-995f-67e29b3207372026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEA-S Medication Solutionsb2e6c30f-a33c-4854-ab19-bc9f658803742026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepacka613cfd3-1aa1-49c5-b742-b105c97d73f12026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Bupropion hydrochlorideBUPROPION HYDROCHLORIDECoupler LLC5604eb14-bab4-4f06-e063-6294a90a69202026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993518
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.867d3876-6974-4e89-bc45-9e60e84b401c2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs4fbe64aa-f8f4-45fa-88ae-e844997703ae2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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