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 13 of 142 · 2,832 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEP	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e246e64-2eab-1219-e063-6294a90a79a8	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOW	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316cd8a3-3d62-83ac-e063-6394a90a4afa	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOW	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e2424f4-0011-42b0-e063-6394a90a780d	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-LIGHT	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316cfaea-b71f-2956-e063-6294a90a4f20	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316d1515-6092-a7d6-e063-6394a90ab8b2	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- MEDIUM DEEP	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e246e70-6ec3-5711-e063-6394a90a3879	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e241343-db63-3f1c-e063-6394a90ab538	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316df5fe-0574-d59f-e063-6294a90af8b9	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- SUN GLOW	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316c5d69-46f4-7677-e063-6294a90a610f	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream	230 N	PML NYC, LLC	316ea01b-4bff-55be-e063-6394a90add94	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream	410 N	PML NYC, LLC	316e97bc-4b96-ba6e-e063-6294a90a7648	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
EltaMD UV Restore Tinted	TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc.	6a48ad0d-20e4-44b1-90d6-30bfbc68a152	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f95cd0a-f996-648b-e063-6294a90adc28	2026-04-16	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f968058-e851-86d0-e063-6294a90aa786	2026-04-16	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Deep)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f970778-97d6-40a9-e063-6394a90a6c89	2026-04-16	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Mineral Sunscreen	TITANIUM DIOXIDE,ZINC OXIDE	Guangdong Aimu Biological Technology Co., Ltd	4f778eb0-55f7-38d0-e063-6394a90a69a0	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f81e482-8111-451c-e063-6294a90ad148	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	UNDRBUDR, LLC	4f8353b3-4ac1-9703-e063-6294a90abdad	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Sunscreen Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	UNDRBUDR, LLC	4f83dd76-a8d8-916e-e063-6294a90ab6ed	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Sunscreen Stick - Tinted	TITANIUM DIOXIDE, ZINC OXIDE	UNDRBUDR, LLC	4f84619f-3415-7443-e063-6394a90a162a	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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