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 56 of 107 · 2,136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e l f Camo Semi Matte CC SPF 30 Light 240 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	8c12a34c-f648-4b55-8265-d430c72ae205	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Light 250 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	0b1c20e6-9d98-4b69-8fe0-ac5e9f2b9b2c	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 370 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	b8d4862e-2671-4b85-8338-f935e0d0194f	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 310 C	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	8d53abee-73bc-4268-b08d-0c196ff4d852	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 375 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	1de296f5-276b-4e8f-8db2-78ea01965c4a	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 610 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	75543b93-8ed9-4c7b-9fcf-99745df5a194	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 620 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	798eecb3-ff6e-46d1-9053-b40e9cd02e5c	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 640 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	cbf949b3-e640-48eb-acf6-fccd6f258865	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 650 C	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	b8bfad36-54b7-42f3-bb5b-5eda1a10f021	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 660 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	853100ea-a9dc-43eb-9715-125b543d2be0	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Tan 400 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	e4f2b579-4886-4e20-a527-c033e9d60bf5	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Tan 460 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	49255019-fa24-4667-b527-ef7189a51f12	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
Clove Hill Tinted Mineral Sunscreen SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Clove Hill LLC	eb2ff5a7-384f-4379-b149-47c1c8c2291d	2025-10-30	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Clove Hill LLC	a37db64d-8b79-40f4-843f-f38949c5b9d2	2025-10-30	Warnings	Exact identifier unii: 15FIX9V2JP
MOOYAM Dark Skin Sunscreen	SUNSCREEN	Guangdong Bisutang Biotechnology Co., LTD	4246e9f1-1c51-d888-e063-6394a90abda0	2025-10-29	Warnings	Exact identifier unii: 15FIX9V2JP
non-tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Clove Hill LLC	311b270f-b9e2-2374-e063-6294a90af581	2025-10-29	Warnings	Exact identifier unii: 15FIX9V2JP
Perricone MD Neuropeptide Restorative Neck and Chest Therapy Broad Spectrum SPF 25	TITANIUM DIOXIDE	THG Beauty USA LLC	23f4cf41-0eed-2df3-e063-6294a90ad402	2025-10-28	Warnings	Exact identifier unii: 15FIX9V2JP
TIBENA EVERYTHING MULTI CUSHION SPF50	HOMOSALATE, TITANIUM DIOXIDE	KONAD CO LTD	421eda8f-62b2-30fb-e063-6394a90a4947	2025-10-27	Warnings	Exact identifier unii: 15FIX9V2JP
PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE	THG Beauty USA LLC	397b4338-fec8-5228-e063-6394a90ad97d	2025-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30	TITANIUM DIOXIDE	THG Beauty USA LLC	38c80373-1d5a-c7f4-e063-6294a90aa9c2	2025-10-23	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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