NDC 68084-059-11 - Zafirlukast

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: 68084-059
Requested NDC: 68084-059-11
Package NDCs from labels: 68084-059-11, 68084-059-21
Manufacturer: American Health Packaging
Effective date: 2024-10-11
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Zafirlukast - American Health Packaging	American Health Packaging	2024-10-11	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-059-11	Zafirlukast	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		7
68084-059-21	Zafirlukast	30 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	30		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-059	ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7	Current NDC, Legacy NDC, 2 package rows	20241013_a60f39f6-d590-4b00-8751-7f12b7ec5385.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-059-11	EA - Each	68084-059	521084b6-0e46-440c-ba5e-d5a7b81c8ffb	1	2013-07-02
68084-059-21	EA - Each	68084-059	2f4d82bb-242a-4ea7-98ec-f18655362a62	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Zafirlukast	ACTIVE INGREDIENT	XZ629S5L50	ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
Zafirlukast	ACTIVE MOIETY	XZ629S5L50	ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	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 107 of 107 · 2,136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cover Recover SPF 30 Taupe	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs, Inc	46e1dc9c-acb8-4a61-8503-065d18c9eb30	2017-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
Cover Recover SPF 30 Cream	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs, Inc	5096ab46-879c-49ec-b0f0-18462814adec	2017-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
Cover Recover SPF 30 Warm Beige	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs, Inc	d8cab2e9-02fd-451c-b0e0-70ba0fc274d5	2017-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
Cover Recover SPF 30 Sand	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs, Inc	e5e8d83e-b3e6-470f-b521-4d7e96ecd1b6	2017-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
Cover Recover SPF 30 Beige	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs, Inc	ec6749b7-377b-4ac5-8992-ac709bd0204e	2017-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
Age Renewal Firming and Hydrating Moisturizer SPF 30	OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	CVS Health	5f6f677d-2404-4e56-a48f-4263314afd9b	2017-03-14	Warnings	Exact identifier unii: 15FIX9V2JP
Your Name Cosmetics Brightening CC Cream Broad Spectrum SPF 20	YOUR NAME COSMETICS BRIGHTENING CC CREAM BROAD SPECTRUM SPF 20	Mana Products	ae6a86d2-a95b-4fa8-9676-233ef9fdc3b0	2017-02-22	Warnings	Exact identifier unii: 15FIX9V2JP
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen	NUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREEN	CVS Pharmacy, Inc	7795e651-838e-41f8-b48d-bd2e0dd1beec	2017-01-18	Warnings	Exact identifier unii: 15FIX9V2JP
DERMAdoctor DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30	DERMADOCTOR DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30	Mana Products	cec89a7e-1670-4d3c-b48c-28ed1ea7f957	2016-12-07	Warnings	Exact identifier unii: 15FIX9V2JP
Age Renewal Firming	OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	AMCOL Health & Beauty Solutions, Inc. DBA	6cb27f87-40a3-4049-aded-eb788509c575	2016-10-07	Warnings	Exact identifier unii: 15FIX9V2JP
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen	NUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREEN	Mana Products	d0e00d97-dbf4-46af-aeda-bdfd6f49b5ab	2016-09-08	Warnings	Exact identifier unii: 15FIX9V2JP
Meijer Kids Tear Free SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Meijer Distribution, Inc.	7415511e-1ecf-4646-b64b-267fbf7d116b	2016-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
Meijer Baby Tear Free SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Meijer Distributing Inc.	2434de23-bcc9-4a83-9945-16fc3f2b8c61	2016-06-01	Warnings	Exact identifier unii: 15FIX9V2JP
TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDE	Allergan, Inc.	6a996e03-907f-4e6a-b232-0892b86956b0	2015-08-21	Warnings	Exact identifier unii: 15FIX9V2JP
Renewal Firming Day Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	BURT'S BEES, INC.	18ceb5d8-4b76-6a54-e054-00144ff88e88	2015-06-18	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD.	30468afc-9616-4765-b046-12e97a0a7827	2010-12-20	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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