FDA.reportPublic FDA data

NDC 55648-101-08 - Bupropion Hydrochloride (SR)

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
55648-101
Requested NDC
55648-101-08
Package NDCs from labels
55648-101-01, 55648-101-02, 55648-101-03, 55648-101-07, 55648-101-08, 55648-101-05
Manufacturer
Wockhardt Limited
Effective date
2012-11-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bupropion Hydrochloride (SR) - Wockhardt LimitedWockhardt Limited2012-11-06HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
55648-101-01PRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
55648-101-02PRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
55648-101-03PRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
55648-101-05PRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
55648-101-07PRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-101-01Bupropion Hydrochloride(SR)30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
55648-101-02Bupropion Hydrochloride(SR)60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602
55648-101-03Bupropion Hydrochloride(SR)100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002
55648-101-05Bupropion Hydrochloride(SR)10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE102
55648-101-07Bupropion Hydrochloride(SR)500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5002
55648-101-08Bupropion Hydrochloride(SR)10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-101BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2Legacy NDC, 6 package rows20121107_1a2a5385-ec04-448f-8bdb-d1cc3eb5f1c0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
AMMONIUM CHLORIDEINACTIVE INGREDIENT01Q9PC255DBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ABUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2

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 1 of 145 · 2,886 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEApotex Corp86530199-999b-9f92-b1bc-b8515ec829f32026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.136f29fa-a859-4efb-8365-1382716d6f8f2026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.81d251aa-a8e8-493e-94ed-12f6fb8902e62026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
BMNP AMMONIUM MURIATICUMAMMONIUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a6a3cb4-aac0-cf5b-e063-6394a90a887d2026-09-01WarningsExact identifier
unii: 01Q9PC255D
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion HCL ER(SR)BUPROPION HCL ER(SR)DriectRx50afb442-e7c6-d28c-e063-6294a90a2b7e2026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 993503
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEGranules Pharmaceuticals Inc.d9eb0939-63c1-48c4-a444-a899d7924d062026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.0b041720-a25d-403e-a72c-601a8bdd80512026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEREMEDYREPACK INC.b47c5515-a438-40bc-b8ad-26a6cf9676b72026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993518
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.6087100f-3ba4-412e-b08d-768d1dcdaf002026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993518
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.0aa86bd6-b37b-45f7-a837-b067e41184e92026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993503
unii: ZG7E5POY8O
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEREMEDYREPACK INC.bcbef1b4-a135-4231-bc65-7d0b335260e82026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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