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 95 of 140 · 2,782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35	OCTINOXATE AND TITANIUM DIOXIDE	MAKEUP ART COSMETICS	2d034810-7210-4ad4-be23-ec2100f8c2f1	2024-12-17	Warnings	Exact identifier unii: 15FIX9V2JP
Cerave Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Deep Sheer Tint	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	a1cab79d-0151-49ee-86dc-c2739842e62e	2024-12-17	Warnings	Exact identifier unii: 15FIX9V2JP
SPF 50 plus Sunscreen	TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE	KAS Direct LLC dba BabyGanics	5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b	2024-12-17	Warnings	Exact identifier unii: 15FIX9V2JP
Even Up Sunscreen SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	f9d375af-3c8b-4462-b729-fdd4be929284	2024-12-17	Warnings	Exact identifier unii: 15FIX9V2JP
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	Bobbi Brown Professional Cosmetics Inc.	dc6b28ca-b922-460a-8028-fb3f5afdbe9d	2024-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30	OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDE	Bobbi Brown Professional Cosmetics Inc.	1f9a4b71-45aa-4156-9fe6-ffa81f808a85	2024-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
Natural Finish Pressed Foundation SPF 20 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	c389e183-bfad-4813-af09-fae3aa05e82a	2024-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
Sunforgettable Total Protection Brush-On Shield SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	c77357f1-7ada-4325-86f7-5ee801610f42	2024-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15	OCTINOXATE, TITANIUM DIOXIDE	Bobbi Brown Professional Cosmetics Inc.	fbd04b66-738b-2762-e053-6394a90a8b72	2024-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
Calming Primer SPF 20	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	d681cdb5-307e-4a2a-8e1d-2b29131d48d0	2024-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Corrector Palette SPF 20 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	ab70122f-bd68-4781-841f-dc83284e1403	2024-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 10	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	0a0654cc-ad47-2167-e063-6294a90a52f4	2024-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40	ZINC OXIDE, TITANIUM DIOXIDE	Babo Botanicals, Inc.	f8adda52-e909-1905-e053-6294a90a3c78	2024-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Babo Botanicals SPF 30 Daily Sheer Tinted Sunscreen - Natural Glow	MINERAL SUNSCREEN	Babo Botanicals, Inc.	ab39d9f0-d869-6f33-e053-2995a90a08d4	2024-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Alumier MD Sheer Hydration	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	88dedeb8-963f-5849-e053-2995a90aab72	2024-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
All Calm Clinical Redness Corrector SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	68b95e94-3686-4d11-9952-ec86394376ee	2024-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	219e2ef4-e977-4527-8999-14b27d5a7a33	2024-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	ee9ae84b-c8fc-4a87-8910-46ec8ccfe1a9	2024-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG DORE SPF 20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	121aa873-5ca6-426b-8ece-dcb5a9f82a03	2024-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN - CC CREME HIGH DEFINITION SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	3421b9a3-6551-406f-af3a-b3da8a01d2b2	2024-12-11	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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