NDC 0378-3634-07 - 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: 0378-3634
Requested NDC: 0378-3634-07
Package NDCs from labels: 0378-3634-01, 0378-3634-05, 0378-3634-07
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 - 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
0378-3634-01	EA - Each	0378-3634	7f950f7e-d309-4533-b98b-f489ce59933a	1	2012-07-24
0378-3634-02	EA - Each	0378-3634	3326a76e-d294-4af3-9664-40e3ca74cd85	1	2013-02-13
0378-3634-05	EA - Each	0378-3634	606980e9-6d8d-4422-b78b-eb68659f5445	1	2012-07-24
0378-3634-07	EA - Each	0378-3634	867efd8d-1722-4c34-9e70-a41ceb37bc74	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 [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	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 3 of 144 · 2,862 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vac-Chord	ALUMINA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BOLDO, CALCAREA CARBONICA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA, HYDRASTIS CANADENSIS, LECITHIN, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MORBILLINUM, PERTUSSINUM, PHYTOLACCA DECANDRA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, THYROIDINUM.	Energetix Corporation	880ea1e6-8d4d-486e-9a8f-9d3158a99667	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tox-Chord	ALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.	Energetix Corporation	b06b4794-e5bb-4ccd-87fd-37afca7b0f98	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Thyro-Chord	HOMEOPATHIC LIQUID	Energetix Corporation	6655b504-dfa8-46df-9d3a-b7fa4078207e	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Chord	HOMEOPATHIC LIQUID	Energetix Corporation	9f8f646e-634a-47ff-b208-b2249d685e55	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
MycoCan-Chord	ALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUM	Energetix Corporation	227199f8-a45e-44ff-892d-ade4fefea354	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
SYSTANE HYDRATION PF PRESERVATIVE FREE	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	8936f66f-10fe-44ab-a26e-dd8b05dfa997	2026-08-10	Warnings	Exact identifier unii: B697894SGQ
Dr. Shitong Photon Energy Eye Care Liquid	TETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUID	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	58ace434-55ef-17ef-e063-6294a90aa878	2026-08-10	Warnings	Exact identifier unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Merz North America, Inc.	d4d4bfcf-3674-4847-8ad8-1716a8e821ae	2026-08-10	Warnings	Exact identifier unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle Sunscreen	TITANIUM DIOXIDE, OCTINOXATE	LCM TECHNOLOGY Co., Ltd	4cbbf8aa-8910-b7e7-e063-6294a90a4f07	2026-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
EltaMD UV Restore	TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	37fee381-ce6b-4949-9a4a-778aa839fb84	2026-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Leader Lubricant Eye Drops 30ct	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CARDINAL HEALTH 110, LLC. DBA LEADER	8df69f2c-40c4-245c-e053-2a95a90a5406	2026-08-05	Warnings	Exact identifier unii: B697894SGQ
ROROBELL WAWA Whitening Tooth	SILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATE	ROROBELL	58336a0d-49dd-ef13-e063-6394a90a38c1	2026-08-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Carvedilol	CARVEDILOL	Redpharm Drug	58337744-a130-35ef-e063-6294a90a080b	2026-08-04	Warnings, Adverse reactions	Exact identifier rxcui: 200031 unii: 0K47UL67F2
Silicea 6X	SILICON DIOXIDE	Hyland's Inc.	db4be3c1-aa7e-24a2-e053-2a95a90a0c66	2026-08-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY	OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%	Lale Cosmetics LLC	581fb0cd-c55d-d562-e063-6394a90a7f11	2026-08-03	Warnings	Exact identifier unii: 15FIX9V2JP
Carvedilol	CARVEDILOL	Coupler LLC	58280d18-5960-1730-e063-6394a90a4f64	2026-08-03	Warnings, Adverse reactions	Exact identifier rxcui: 686924 unii: 0K47UL67F2
EltaMD UV Active	ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc	39d16479-d491-4c19-aa11-674461687c7b	2026-08-03	Warnings	Exact identifier unii: 15FIX9V2JP
Coreg	CARVEDILOL	Waylis Therapeutics LLC	07c619c6-4a0c-445e-94fa-664a54f68a39	2026-07-31	Warnings, Adverse reactions	Exact identifier rxcui: 200032 rxcui: 200031 rxcui: 200033 rxcui: 686924 unii: 0K47UL67F2
Continuous Correction Cream	TITANIUM DIOXIDE	Baxter of California, LLC	1cbcc648-f2e1-af60-e063-6294a90ad4bb	2026-07-31	Warnings	Exact identifier unii: 15FIX9V2JP
Cover Creme	TITANIUM DIOXIDE	Baxter of California	31f5e8c4-523f-4596-e063-6294a90a6a12	2026-07-31	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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