NDC 68084-446-11 - Nitrofurantoin (monohydrate/macrocrystals)

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: 68084-446
Requested NDC: 68084-446-11
Package NDCs from labels: 68084-446-11, 68084-446-01
Manufacturer: American Health Packaging
Effective date: 2022-10-19
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Nitrofurantoin (monohydrate/macrocrystals) - American Health Packaging	American Health Packaging	2022-10-19	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-446-01	EA - Each	68084-446	3531bb3c-0cf0-4c41-ac4f-07e04cce7341	1	2012-07-24
68084-446-11	EA - Each	68084-446	c2e616ac-22cd-4470-8909-ecaf9f724e9b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NITROFURANTOIN	ACTIVE INGREDIENT	927AH8112L	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
NITROFURANTOIN MONOHYDRATE	ACTIVE INGREDIENT	E1QI2CQQ1I	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
NITROFURANTOIN	ACTIVE MOIETY	927AH8112L	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [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 36 of 142 · 2,832 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perfect Glow BB Cream Sunscreen SPF 30 - Light Warm	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47325530-b097-db9a-e063-6294a90a335d	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Tan	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47328eb4-8ad7-28b5-e063-6294a90a20b1	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Tan Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4732bbec-d9f9-1639-e063-6394a90aff82	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4732ecd0-5261-7f11-e063-6394a90a26f3	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
ONETOOTHCLINIC TOOTH	SILICON DIOXIDE, TOCOPHEROL ACETATE, SODIUM PYROPHOSPHATE	CONE MEDICAL Co., Ltd.	9a567c9e-b8ce-7bf1-e053-2995a90aff2b	2025-12-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
ONETOOTH CLINIC TOOTH	SILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATE	CONE MEDICAL Co., Ltd.	bd50abcd-8a85-2923-e053-2995a90a109b	2025-12-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Fair	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	473738b4-7c36-8edf-e063-6394a90ad24b	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Medium Tan	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47387d5f-e77b-5633-e063-6294a90a5584	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4738be66-0fe8-148e-e063-6394a90a1b02	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan Deep	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4738eed1-9f72-5fd8-e063-6394a90a26bd	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Deep	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4739179e-88b3-8820-e063-6394a90aa211	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
CVS Advanced Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	CVS Pharmacy, Inc.	f74a2fca-902c-f68a-e053-6394a90abb88	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Good Sense Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Geiss, Destin & Dunn, Inc.	9b243301-2e4b-5706-e053-2995a90a9b90	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Geiss, Derstin & Dunn, Inc.	9b34de99-13df-201a-e053-2a95a90ae559	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Discount Drug Mart Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Discount Drug Mart, Inc.	f75c2f84-a28c-5807-e053-6294a90a2295	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Exchange Select Eye Drops Advanced Relief Moisturizer	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Army and Air Force Exchange Service	9e475240-2df1-9bee-e053-2995a90a8d4b	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Family Wellness Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Family Dollar Services, Inc.	facd329b-1923-61df-e053-6294a90ab738	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
DG Health Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Dolgencorp LLC	9c62f8a3-7cf5-40f9-e053-2a95a90afd86	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	KC Pharmaceuticals, Inc.	eb6eb6c4-1609-407b-84e4-c7509811f3c0	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Medics Choice Eye Drops Advanced	TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE	KC Pharmaceuticals, Inc.	ab906fd8-265c-4359-a920-d626366e245c	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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