NDC 51079-109-01 - 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: 51079-109
Requested NDC: 51079-109-01
Package NDCs from labels: 51079-109-01, 51079-109-03
Manufacturer: Mylan Institutional Inc.
Effective date: 2018-11-20
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Bupropion Hydrochloride - Mylan Institutional Inc.	Mylan Institutional Inc.	2018-11-20	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-109-01	EA - Each	51079-109	b9018094-3c24-499d-8608-026edf7d080c	1	2012-07-24
51079-109-03	EA - Each	51079-109	78ebe57d-abdc-48f5-a798-f59fcbf224e8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6

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 55 · 1,094 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lymph Tonic II	ECHINACEA (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 RANA	BioActive Nutritional, Inc.	0e3265b0-b210-4a4c-80d2-8a9712981d4e	2026-09-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
Leader Artificial Tears 15 mL	POLYVINYL ALCOHOL, POVIDONE	Cardinal Health	8cccc589-3a8e-baad-e053-2a95a90ab8c7	2026-09-09	Warnings	Exact identifier unii: 532B59J990 unii: FZ989GH94E
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Apotex Corp	86530199-999b-9f92-b1bc-b8515ec829f3	2026-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: ZG7E5POY8O
Psoriasis Control	CENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDE	Forces of Nature	2db33771-0bb9-49f8-84fa-dddc28e4ba26	2026-09-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS	POVIDONE, POLYVINYL ALCOHOL SOLUTION	Harrow Eye, LLC	049e9cc9-0663-53bc-e063-6294a90a2c4f	2026-09-04	Warnings	Exact identifier unii: 532B59J990 unii: FZ989GH94E
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	136f29fa-a859-4efb-8365-1382716d6f8f	2026-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: ZG7E5POY8O
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	81d251aa-a8e8-493e-94ed-12f6fb8902e6	2026-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: ZG7E5POY8O
BMNP Silicea	SILICEA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	5a58454f-aed6-24ba-e063-6294a90a47fb	2026-08-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Bupropion HCL ER(SR)	BUPROPION HCL ER(SR)	DriectRx	50afb442-e7c6-d28c-e063-6294a90a2b7e	2026-08-31	Warnings, Adverse reactions	Exact identifier unii: ZG7E5POY8O
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Granules Pharmaceuticals Inc.	d9eb0939-63c1-48c4-a444-a899d7924d06	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: ZG7E5POY8O
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	0b041720-a25d-403e-a72c-601a8bdd8051	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: ZG7E5POY8O
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	b47c5515-a438-40bc-b8ad-26a6cf9676b7	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: ZG7E5POY8O
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	6087100f-3ba4-412e-b08d-768d1dcdaf00	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: ZG7E5POY8O
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	0aa86bd6-b37b-45f7-a837-b067e41184e9	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: ZG7E5POY8O
Argentum Quartz	ARGENTUM QUARTZ	Uriel Pharmacy Inc.	765c8c8f-0727-45da-a77e-c3907a3d0793	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	bcbef1b4-a135-4231-bc65-7d0b335260e8	2026-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: ZG7E5POY8O
Endometrium Argentum	ENDOMETRIUM ARGENTUM	Uriel Pharmacy Inc	d2d1428a-c8b5-9529-e053-2995a90a2343	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
S12 AIRBORNE	ALFALFA, 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, WHEAT	Apex Energetics Inc.	bb0036c3-1e4d-5750-e053-2995a90ae895	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	56df4e22-81ca-48a4-a8e2-038448417355	2026-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: ZG7E5POY8O
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5f8b3313-0286-499f-9235-02cdc0eb063b	2026-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: ZG7E5POY8O

Reported adverse events (FAERS/openFDA)#

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