NDC 65862-638-10 - Irbesartan

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: 65862-638
Requested NDC: 65862-638-10
Package NDCs from labels: 65862-638-30, 65862-638-90, 65862-638-05, 65862-638-10, 65862-638-78
Manufacturer: Aurobindo Pharma Limited
Effective date: 2025-11-21
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Irbesartan - Aurobindo Pharma Limited	Aurobindo Pharma Limited	2025-11-21	Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-638-05	Irbesartan	500 in 1 BOTTLE	TABLET	500	11
65862-638-10	Irbesartan	10 in 1 BLISTER PACK	TABLET	10	11
65862-638-30	Irbesartan	30 in 1 BOTTLE	TABLET	30	11
65862-638-78	Irbesartan	10 in 1 CARTON	TABLET	10	11
65862-638-90	Irbesartan	90 in 1 BOTTLE	TABLET	90	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-638	IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]	9	Current NDC, Legacy NDC, 5 package rows	20240516_2113a901-2612-4557-b86d-3afc006fb8bb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-638-05	EA - Each	65862-638	c8b4e102-872e-47e6-882f-798460734d84	1	2013-02-13
65862-638-30	EA - Each	65862-638	159dded5-bff9-4ca3-a53f-87add3a0b3a8	1	2013-02-13
65862-638-90	EA - Each	65862-638	ff86da6c-b99d-444b-be14-248305869ba9	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IRBESARTAN	ACTIVE INGREDIENT	J0E2756Z7N	IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]	2
IRBESARTAN	ACTIVE MOIETY	J0E2756Z7N	IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]	2
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IRBESARTAN TABLET [AUROBINDO PHARMA 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 2 of 34 · 674 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lymph-Tone II	AESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC.	Energetix Corporation	c46aa8d3-4aa5-4e07-be3d-d71abc5e2407	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lymph-Tone III	ADENOSINUM CYCLOPHOSPHORICUM, ARNICA, BOLDO, CALC IOD, CALENDULA, CARTILAGO SUIS, CEANOTHUS, COENZYME A, ECHINACEA, HAMAMELIS, HEPAR SULPH CALC, HYPOTHALAMUS, NADIDUM, NAJA, NAT SULPHURICUM, PHASEOLUS, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PYROGENIUM, SILICEA, SULPHUR, THUJA OCC, THYROIDINUM, VISCUM	Energetix Corporation	4c9ae54c-ce7d-4276-add7-2922a8f0e310	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Metabopath	ADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,	Energetix Corporation	58bfe670-d308-45a2-8046-7897b6221452	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
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
Irbesartan	IRBESARTAN	Macleods Pharmaceuticals Limited	e8635a1c-ae06-4e23-99f7-e704f91d6f43	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 200096 rxcui: 200095 rxcui: 200094 unii: J0E2756Z7N
IRBESARTAN	IRBESARTAN	Hisun Pharmaceuticals USA Inc.	61ab1b6e-c849-49ca-a3f0-150774db649d	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 200096 rxcui: 200095 rxcui: 200094 unii: J0E2756Z7N
ROROBELL WAWA Whitening Tooth	SILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATE	ROROBELL	58336a0d-49dd-ef13-e063-6394a90a38c1	2026-08-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Silicea 6X	SILICON DIOXIDE	Hyland's Inc.	db4be3c1-aa7e-24a2-e053-2a95a90a0c66	2026-08-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Smogstat	ECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA	Energique, Inc.	59f63e2b-24fa-43a0-8334-02e6729c6ac1	2026-07-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Muscle Ice	PHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)	Peaceful Mountain, Inc.	03b6e2a9-f335-4ae2-9011-80bd019afb72	2026-07-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Bioplasma	SILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDE	Hyland's Inc.	dd0a7ed2-d112-4b96-e053-2995a90ac6b6	2026-07-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	5b259fdd-ca4c-49c9-a50d-86066f5b0746	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 200094 unii: J0E2756Z7N
Droptics Dry Eye Relief	CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80	Droptics LLC	29d7614b-f4b7-48e2-97c5-d1bff27731d2	2026-07-22	Warnings	Exact identifier unii: 6OZP39ZG8H
Prid	ICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFUR	Hyland's Inc.	49689eeb-7790-07f1-e063-6294a90a2df2	2026-07-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
Leg Cramps PM	OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFUR	Hyland's Inc.	b0574a7e-88fa-417e-b6d5-60ced59eba47	2026-07-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	029a90b6-0722-49be-8400-3ec29526aafd	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 200095 unii: J0E2756Z7N

Reported adverse events (FAERS/openFDA)#

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