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 89 of 140 · 2,782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS	OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE	Biocosmetica Exel Argentina SRL	2aad5b97-e64b-c678-e063-6294a90aa8c6	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
NativeRemedies Acid Free-Flux	CALC PHOS 9X, CARBO VEG 6C, MAG CARB 6C, NAT PHOS 9X, SILICEA 9X	Silver Star Brands	d5012b1f-861e-40b8-e053-2a95a90a4fe2	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
Mucus Clear Allergy Relief	ALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICA	Silver Star Brands	f49bdcc1-1939-6dc2-e053-2995a90a0a3b	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
NativeRemedies Gout-Gone	ANTIMON CRUD, BENZOICUM AC, LEDUM, NUX VOM, QUERCUS, RHODODENDRON, SILICEA	Silver Star Brands	f66b42f0-8f5f-1aca-e053-2a95a90ae396	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
NeuropathEase	AGARICUS MUSC, ARSENICUM ALB, HYPERICUM, PHOS, SILICEA	Silver Star Brands	7809e54a-018d-9cf6-e053-2a91aa0aedfe	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
AllergiClear-M	ADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEA	Silver Star Brands	9d36096b-022f-5cfa-e053-2995a90a381f	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	fmg Co.Ltd	d30ac897-3a30-7bba-e053-2995a90ac342	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot Beige	ENSULIZOLE, TITANIUM DIOXIDE	fmg Co.Ltd	d30b0588-b0f4-39a8-e053-2a95a90abb35	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	fmg Co.Ltd	d30aeaa6-3423-401c-e053-2a95a90a8fe9	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Cushion CC Total Cover SPF 50 Natural Beige	ENSULIZOLE, TITANIUM DIOXIDE	fmg Co.Ltd	d30afd94-8bcd-01bc-e053-2a95a90afb49	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	d30b156a-b9b1-499b-e053-2a95a90ada6a	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	d30b183d-a54d-752c-e053-2a95a90a24fc	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 01 Light Beige	TITANIUM DIOXIDE	fmg Co.Ltd	d3078dd2-ae9c-d81a-e053-2a95a90a47bf	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige	TITANIUM DIOXIDE	fmg Co.Ltd	d3078dd2-ae9e-d81a-e053-2a95a90a47bf	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	f8377d02-6c58-c240-e053-6294a90a44c0	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	d2fadd51-6bd8-ae70-e053-2995a90a6213	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d309eebc-44f4-bce6-e053-2995a90a3bd2	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a3bcb-5113-0a85-e053-2995a90a3937	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	d30a9f96-f99b-4610-e053-2995a90a3f91	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot Beige	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a7ecc-ea54-d1b9-e053-2995a90a7017	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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