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 124 of 139 · 2,765 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Artistry Exact Fit Longwearing Foundation Shade Golden L4N1	TITANIUM DIOXIDE	Amway Corp	7494fe09-40e0-4152-9974-a6e8a4d7f421	2023-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Soleil L3W1	TITANIUM DIOXIDE	Amway Corp	cec51b88-a6b8-4b64-b3aa-830e712a3c8a	2023-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Tawny L3N1	TITANIUM DIOXIDE	Amway Corp	706e1504-fad7-44fa-9030-f5b948e3e79b	2023-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Cappuccino L5W1	TITANIUM DIOXIDE	Amway Corp	b785af89-1134-4fc6-8388-c47c52d153e0	2023-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Natural L2N2	TITANIUM DIOXIDE	Amway Corp	db24e10a-6957-4ce7-8b03-572caacc647a	2023-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Caramel L5N1	TITANIUM DIOXIDE	Amway Corp	e7d8616d-3e79-4b5e-b05b-fbb506c0203d	2023-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Plush L3C1	TITANIUM DIOXIDE	Amway Corp	ff387c87-4ada-41c6-b62b-07a143213770	2023-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Walnut L6N1	TITANIUM DIOXIDE	Amway Corp	48c0bb8b-2f89-465e-9ae6-98690a2f877c	2023-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Light/Medium	ENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	Amway Corp	830a748f-bb14-47f6-ab6f-48d8bd706321	2023-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Med/Deep	ENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	Amway Corp	20c432e2-4c63-485b-9dd5-2bc73b6f4285	2023-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Ideal Radiance Illuminating CC SPF50 Broad Spectrum Sunscreen - Light	ENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	Access Business Group LLC	070f9538-4b36-471a-aa06-6669e9ecfdf0	2023-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Medium	ENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	Amway Corp	40a82d20-b84b-4ae8-818d-1f503ceef581	2023-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation SPF 15 Broad Spectrum Sunscreen	TITANIUM DIOXIDE	Amway Corp	a83f1192-c6c7-4145-b5af-29202191db78	2023-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Buff L1W1	TITANIUM DIOXIDE	Amway Corp	cba2462d-71ec-4ecb-b05a-5208ff8e22ad	2023-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Brule L4W1	TITANIUM DIOXIDE	Amway Corp	19d08a86-5a60-4633-8a3c-96bab9a17fcc	2023-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Chablis L1C1	TITANIUM DIOXIDE	Amway Corp	d17b1d46-478e-4f48-8fde-ac639bcdc492	2023-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Chiffon L2C1	TITANIUM DIOXIDE	Amway Corp	750ca57c-e8e9-4be0-84b1-7f55487f7bf6	2023-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Cream L1W2	TITANIUM DIOXIDE	Amway Corp	192dac09-2887-4622-b3d4-c6a9c16b4f88	2023-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Mink L6W1	TITANIUM DIOXIDE	Amway Corp	af6d38d5-69ab-4d7e-b534-b2c2bcf36847	2023-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Ochre L2N1	TITANIUM DIOXIDE	Amway Corp	7f545d32-b38c-4f6a-a413-7f29e1aa2bc3	2023-10-21	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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