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 95 of 107 · 2,136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	43c81760-6bb6-25fe-e054-00144ff8d46c	2023-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Erborian CC Dull Correct SPF25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	cb23ba95-1e83-4523-a35c-3b70c0605dd1	2023-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	ac2d5713-9955-477e-a10f-e8a1191b5fdd	2023-12-07	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1720cff-a897-68cb-e053-2995a90a30b6	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12272c3-d4ed-2212-e053-2995a90add37	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12272c3-d4f0-2212-e053-2995a90add37	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1228ca6-8fb4-5964-e053-2a95a90a30ca	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12292a8-c98f-eb27-e053-2a95a90a9bbc	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skin	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields	b7401ff8-ca47-4c74-813c-99c5f28c0b6d	2023-12-04	Warnings	Exact identifier unii: 15FIX9V2JP
Perbelle CC SPF43 UVA UVB Broad Spectrum	TITANIUM DIOXIDE	Perbelle Cosmetics Global Ltd.	b5e2724e-9806-5bcc-e053-2a95a90a0508	2023-12-01	Warnings	Exact identifier unii: 15FIX9V2JP
Zafirlukast	ZAFIRLUKAST	Aurobindo Pharma Limited	8bdb47c5-9d19-4d59-94c8-62c117525e7f	2023-12-01	Warnings, Adverse reactions	Exact identifier rxcui: 313758 rxcui: 199655 unii: XZ629S5L50
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1228d15-a157-6989-e053-2995a90a44ea	2023-12-01	Warnings	Exact identifier unii: 15FIX9V2JP
SOOTHE Daily Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields	9acbf663-15e4-4572-a267-56afa58a347b	2023-11-30	Warnings	Exact identifier unii: 15FIX9V2JP
SPF 60 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Derma Care Research Labs, LLC	0aae69f1-66bf-a199-e063-6394a90a3d75	2023-11-21	Warnings	Exact identifier unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Rite Aid	0a9c1b3f-656d-0d62-e063-6394a90a4731	2023-11-20	Warnings	Exact identifier unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	581e8289-1406-45b6-9786-753800665fad	2023-11-20	Warnings	Exact identifier unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Rite Aid	0a4cea12-7e00-d201-e063-6394a90a6691	2023-11-16	Warnings	Exact identifier unii: 15FIX9V2JP
Max Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Peter Thomas Roth Labs, LLC	0980992c-6488-2fa1-e063-6294a90a41ea	2023-11-14	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands, SPF-50 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	493551d0-10a0-3d78-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	494a7886-d677-1648-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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