NDC 0378-3633-02 - Carvedilol

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: 0378-3633
Requested NDC: 0378-3633-02
Package NDCs from labels: 0378-3633-01, 0378-3633-05, 0378-3633-02
Manufacturer: Mylan Pharmaceuticals Inc.
Effective date: 2024-08-29
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Carvedilol - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2024-08-29	HUMAN PRESCRIPTION DRUG LABEL
Carvedilol - Mylan Institutional Inc.	Mylan Institutional Inc.	2024-07-31	HUMAN PRESCRIPTION DRUG LABEL
Carvedilol - Northwind Pharmaceuticals	Northwind Pharmaceuticals	2014-05-16	HUMAN PRESCRIPTION DRUG LABEL
Carvedilol - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2014-05-12	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2013-02-13	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
0378-3633-01	EA - Each	0378-3633	8fccb445-c462-455b-a6f2-21b81ca556ef	1	2012-07-24
0378-3633-02	EA - Each	0378-3633	5afcb926-e748-4fb5-bedc-d67f20d6c9d8	1	2013-02-13
0378-3633-05	EA - Each	0378-3633	90d8adb1-4464-4c1e-99a8-eca6706cedcf	1	2012-07-24
0378-3633-07	EA - Each	0378-3633	4fb5d782-f337-49c7-93b8-667caf12ccb2	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	5
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]	1
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

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 144 · 2,863 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
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier unii: 15FIX9V2JP
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	d7d6bfff-fbb6-4a1f-aa13-babbb9a1e878	2026-09-09	Warnings, Adverse reactions	Exact identifier rxcui: 200032 unii: 0K47UL67F2
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
Dr.Harry EYES PROTECTION	POLYETHYLENE GLYCOL 400 1% EYES PROTECTION	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5a9fe033-89d3-da62-e063-6294a90a4503	2026-09-03	Warnings	Exact identifier unii: B697894SGQ
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
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Lightweight Sunscreen	AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	59eeaea1-d726-99f3-e063-6394a90aeea3	2026-08-26	Warnings	Exact identifier unii: 15FIX9V2JP
Argentum Quartz	ARGENTUM QUARTZ	Uriel Pharmacy Inc.	765c8c8f-0727-45da-a77e-c3907a3d0793	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Carvedilol	CARVEDILOL	St. Mary's Medical Park Pharmacy	8a82149f-aade-2a9b-e053-2995a90a9daf	2026-08-26	Warnings, Adverse reactions	Exact identifier rxcui: 200032 unii: 0K47UL67F2
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
Q Skin Science	SUNSCREEN	International Cosmeceuticals, Inc	59e4c3d0-ee4c-2350-e063-6394a90ac9d2	2026-08-25	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO zinc stick(GREEN)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c70c82-f7ff-9a04-e063-6294a90a7b3d	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	59d74e3f-e3fa-a7a9-e063-6294a90a76e5	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
Aging Eye Formula	CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUM	Nutritional Specialties, Inc.	d5b44f79-5299-4b31-ba45-0e511cdbe17c	2026-08-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
Rohto All-In-One	HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE	The Mentholatum Company	43e690e4-b381-46e3-838c-33aef5bdadde	2026-08-20	Warnings	Exact identifier unii: 3NXW29V3WO
Bio Combination 28	SCHUESSLER SALTS	LDD Bioscience Private Limited	597caf33-5107-9dec-e063-6294a90a5fcd	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body Original	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc.	4bbde755-e312-123e-e063-6294a90a467f	2026-08-20	Warnings	Exact identifier unii: 15FIX9V2JP
Psorinum Complex	PHOSPHORUS, SILICEA, SULPHUR, ALOE	BioActive Nutritional, Inc.	d4746927-e6d4-463d-a084-56ffc48d1e67	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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