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 119 of 139 · 2,765 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	ab691543-e37a-487a-912e-56d2e0e4d30a	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
PURE HAVEN BODY SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Pure haven, LLC	6f298fcd-8a97-8f66-e053-2991aa0adb10	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Sunstation All-Natural SPF 30 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Sunstation USA, LLC	499d366a-a7f1-6070-e054-00144ff88e88	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Pure Haven Essentials	TITANIUM DIOXIDE, ZINC OXIDE	Pure Haven LLC	4bccc017-266d-11ce-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Kapa'ihi, Inc	66e5eb1b-4ef0-459d-8428-b3e2f221bc85	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
YOU-V SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	YouV, LLC	290cd617-aa90-4f10-8a1d-d8954b927004	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30	TITANIUM DIOXIDE	Coral Reef Park Co., Inc.	743f3d23-0f5c-4724-9f69-411c109506e1	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
ONCODERM Rx Mineral Sunscreen SPF-30	TITANIUM DIOXIDE, ZINC OXIDE	Oncoderm, LLC	9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
PROJECT REEF Mineral Sunscreen SPF-50	ZINC OXIDE, TITANIUM DIOXIDE	Project Reef LLC	87b9170c-956e-4aa2-9416-da00cca81b58	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
DERMAKA Broad Spectrum SPF-42 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	DERMAKA SKIN PRODUCTS	32b892fd-c68f-4670-bbaa-0b3de5712849	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
WILMA SCHUMANN Moisture Protektiv Day Cream SPF-20	OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE	SKINMETICS INC	4a719986-d1d0-4156-b803-04004b721504	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted	TITANIUM DIOXIDE, ZINC OXIDE	DERMAKA SKIN PRODUCTS	9aa24e1f-e338-4947-a437-554fb6b227a2	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
TRENDY JOHN SPF-32 Sheer Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	TRENDY JOHN LLC	80dccecb-fbb3-4af6-9cb4-6acea733e996	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Women	TITANIUM DIOXIDE, ZINC OXIDE	ACTIVE LIFE INC	0ddc3bb9-595e-4ebd-ad3e-df4d94fd34ed	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Personalized Day Moisturizer with SPF	TITANIUM DIOXIDE, ZINC OXIDE	Proven Skincare	3b6546ed-22ee-48e6-83cc-5cbadf567499	2023-11-10	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut)	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	4935f888-cd92-61d1-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier unii: 15FIX9V2JP
Coral Safe SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	4925a507-863f-1088-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier unii: 15FIX9V2JP
CoralSafe Broad Spectrum SPF30	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands	e6e00896-b7e5-41c6-a72b-08e600758cf5	2023-11-10	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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