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 92 of 140 · 2,782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RV Illuminance Serum Tint Broad Spectrum 15 Amber	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b311f-9dcc-9b26-e063-6394a90a29a8	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Buff Beige	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b3b8b-d38b-cd4d-e063-6294a90a919a	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Hazel	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b3b8b-d38c-cd4d-e063-6294a90a919a	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Cool Beige	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b48b8-5953-9ab7-e063-6394a90a6b24	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Creamy Natural	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b311f-9dcd-9b26-e063-6394a90a29a8	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Rich Mahogany	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b6b99-883b-ffd4-e063-6294a90a7f4b	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Light Tan	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b557a-ff60-f33f-e063-6394a90ac66f	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Light Beige	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b6b99-8839-ffd4-e063-6294a90a7f4b	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Light Natural	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b668d-036e-893e-e063-6294a90a82af	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Rich Sand	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b6ba3-b5da-f2f7-e063-6394a90a86ae	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Soft Nutmeg	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b856a-d714-892c-e063-6294a90a4ae9	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Sandalwood	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b856a-d712-892c-e063-6294a90a4ae9	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Tan Sand	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b5cca-4e4f-efb6-e063-6294a90a6206	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Warm Caramel	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b9147-3c7a-d549-e063-6394a90a6869	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	aefd7884-6bc3-4b0b-ba36-1f3e8fe49f93	2024-12-23	Warnings	Exact identifier unii: 15FIX9V2JP
Kids SPF50Plus Mineral Sunscreen Rollerball Totally Tropical	ZINC OXIDE AND TITANIUM DIOXIDE	KAS Direct LLC dba BabyGanics	d3bdda65-bcb4-42d9-84af-d14c7f4421bd	2024-12-23	Warnings	Exact identifier unii: 15FIX9V2JP
Kids SPF50 Plus Mineral Sunscreen Continuous Totally Tropical	ZINC OXIDE AND TITANIUM DIOXIDE	KAS Direct LLC dba BabyGanics	d5ffe993-de8f-4623-a010-9cb8dd70de07	2024-12-23	Warnings	Exact identifier unii: 15FIX9V2JP
CERAVE Hydrating Mineral Sunscreen Light Sheer Tint Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	8b298516-70df-47ab-834f-51dcde28a43a	2024-12-23	Warnings	Exact identifier unii: 15FIX9V2JP
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	6a14ee23-28c9-4704-8af9-d1c4db0d9256	2024-12-23	Warnings	Exact identifier unii: 15FIX9V2JP
EcoStick Sunscreen SPF 35	ZINC OXIDE, TITANIUM DIOXIDE	Stream2Sea, LLC	eba17b7a-5e96-4462-9b71-44c2bc577dce	2024-12-21	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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