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 106 of 107 · 2,136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zafirlukast	ZAFIRLUKAST	Camber Pharmaceuticals, Inc.	5d30ffab-38a1-411d-94ad-0a15c227d882	2020-09-14	Warnings, Adverse reactions	Exact identifier rxcui: 313758 rxcui: 199655 unii: XZ629S5L50
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Vanilla	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	d701c221-9f68-47ff-b766-2f4f1998649f	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Amber	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	7f5e6872-4d26-410e-8afe-16a016f9a399	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm Ivory	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	1124ba7d-a328-409b-8c88-e74bb3e501f5	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Honey	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	9c407dc7-fcde-4660-9a06-57bd8a6b867d	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Chestnut	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	f07e8bb2-30ae-4337-ad60-84f55f2ff354	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Golden Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	b7a4847f-b84d-4f36-8787-104eccd838a0	2018-12-03	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Warm Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	229c20a3-6288-4ac3-9098-6d1622e906ab	2018-11-29	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Warm Medium Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	fc90fb8a-44b3-47cd-882e-94ed324ed389	2018-11-27	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Warm Medium	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	b585f216-4234-47c5-9a6b-8b133ef48aae	2018-11-27	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Warm Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	14891e26-b3b6-4545-99b1-da914b7f5629	2018-11-24	Warnings	Exact identifier unii: 15FIX9V2JP
Zafirlukast	ZAFIRLUKAST	Dr. Reddys Laboratories Limited	6ccb96af-2647-9206-5eee-49a825d32488	2018-11-16	Warnings, Adverse reactions	Exact identifier application number: ANDA090372 ndc (product): 55111-626 rxcui: 313758 rxcui: 199655 spl id: b5fb9efb-3369-e1f9-384c-bd22e8ecad92 spl set id: 6ccb96af-2647-9206-5eee-49a825d32488 unii: XZ629S5L50
Additox	TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	BioActive Nutritional, Inc.	319ee2fe-58e3-495e-bf0d-df201f6fbb1c	2018-07-18	Warnings	Exact identifier unii: 15FIX9V2JP
Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20	YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20	Mana Products	657d5090-30a8-46d0-879d-469178aa234d	2018-01-25	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Sunscreen Moisturizer Broad Spectrum SPF 20	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs, Inc	316c2132-ab81-47f6-8e80-71e9252a2663	2017-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Sunscreen Broad Spectrum SPF 45	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs, Inc	96d2d0f1-dbde-4b66-9b2c-9d07f7547066	2017-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
Cover Recover SPF 30 Ivory	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs, Inc	fe207b88-8eb8-424d-89b4-8d5b188dd2c3	2017-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
Cover Recover SPF 30 Tawny	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs, Inc	94d604d4-b0bf-4f3e-888c-b6104241925b	2017-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
Cover Recover SPF 30 Cocoa	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs, Inc	9f6a5740-174c-4244-b291-6ab6367ce512	2017-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
SkinPerfect Primer SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Dermalogica, Inc.	5fc75cef-5b76-44ab-891a-7b90c04a0681	2017-12-05	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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