NDC 69339-159-01 - Itraconazole Oral

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: 69339-159
Requested NDC: 69339-159-01
Package NDCs from labels: 69339-159-01, 69339-159-17
Manufacturer: Natco Pharma USA LLC | Annora Pharma Private Limited
Effective date: 2023-08-05
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Itraconazole Oral - Natco Pharma USA LLC \| Annora Pharma Private Limited	Natco Pharma USA LLC \| Annora Pharma Private Limited	2023-08-05	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69339-159-01	Itraconazole Oral	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10		2
69339-159-17	Itraconazole Oral	40 in 1 BOX, UNIT-DOSE	SOLUTION	40		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69339-159	ITRACONAZOLE ORAL (ITRACONAZOLE) SOLUTION [NATCO PHARMA USA LLC]	2	Current NDC, Legacy NDC, 2 package rows	20230902_da63870d-b426-4e49-9591-5bb51f962e66.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69339-159-01	ML - Milliliter	69339-159	6c2811ce-c431-4a7f-a075-b13765858a8e	1	2022-05-04
69339-159-17	ML - Milliliter	69339-159	ddd59faa-e4cb-43f8-b1d4-19964974f5a0	1	2022-05-04

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 25 of 25 · 490 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GUNA-DIGEST	ANGELICA ARCHANGELICA ROOT - ANISUM - ARTEMISIA ABROTANUM FLOWERING TOP - ASCORBIC ACID - CITRULLUS COLOCYNTHIS FRUIT PULP - GENTIANA LUTEA ROOT - MELATONIN - NIACIN - PANCRELIPASE AMYLASE - PANCRELIPASE LIPASE - PORK LIVER - SEROTONIN - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA DIENCEPHALON - SUS SCROFA DUODENUM - SUS SCROFA GALL BLADDER - SUS SCROFA PANCREAS - SUS SCROFA PYLORUS - THIAMINE HYDROCHLORIDE - TRYPSIN - TRYPTOPHAN -	Guna spa	624228b9-70be-43a1-93a5-f6e708814fa2	2018-12-22	Warnings	Exact identifier unii: PQ6CK8PD0R
GUNA-SINUS NOSE	ALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER -	Guna spa	36fef678-17c6-4d2a-a0f0-ddb298611f25	2018-12-22	Warnings	Exact identifier unii: PQ6CK8PD0R
GUNA-RHINO NOSE	APIS MELLIFERA - ARALIA RACEMOSA ROOT - ASCORBIC ACID - BLACK CURRANT - COPPER - EUPHORBIA RESINIFERA RESIN - EUROPEAN ELDERBERRY - HELIANTHEMUM CANADENSE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED) - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - MELILOTUS - ONION - PLANTAGO MAJOR - ROSA CANINA FRUIT - SILVER NITRATE -	Guna spa	5baeb698-1735-4586-9984-2a2cb0da871a	2018-12-21	Warnings	Exact identifier unii: PQ6CK8PD0R
OMEOSPORT	.ALPHA.-KETOGLUTARIC ACID - ACONITIC ACID, CIS - ADENOSINE TRIPHOSPHATE - ALPHA LIPOIC ACID - ASCORBIC ACID - ASIAN GINSENG - BARIUM CATION - BEET - CEROUS OXALATE NONAHYDRATE - COENZYME A - CYSTEINE - FUMARIC ACID - LACTIC ACID, DL - MAGNESIUM CARBONATE - MALIC ACID - MANGANESE PHOSPHATE, DIBASIC - PORK - PYRIDOXINE HYDROCHLORIDE - RIBOFLAVIN - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SUCCINIC ACID - SUS SCROFA ADRENAL GLAND - THIAMINE HYDROCHLORIDE - SUS SCROFA EMBRYO -	Guna spa	119a205d-0074-48ff-ac78-e2300db45227	2018-12-21	Warnings	Exact identifier unii: PQ6CK8PD0R
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier unii: 059QF0KO0R
Bio Rock Water	ROCK WATER	BioActive Nutritional, Inc.	178bd16d-0d4f-49d8-866b-8ab3a3c6889d	2018-07-30	Warnings	Exact identifier unii: 059QF0KO0R
Immuno Fortifier	ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LIGUSTICUM PORTERI, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, TRIGONELLA FOENUM-GRAECUM, ASCORBIC ACID, PINUS SYLVESTRIS, LYMPH (SUIS), MEDULLA OSSIS SUIS, SPLEEN (SUIS), THYMUS (SUIS), HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, SILICEA	BioActive Nutritional, Inc.	04024663-0b11-438a-a21a-8e86edd8052a	2018-01-15	Warnings	Exact identifier unii: PQ6CK8PD0R
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye Wash	WATER	CVS Pharmacy	049cee29-7ec2-4d5b-8308-f522acde43a7	2017-03-29	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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