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 104 of 139 · 2,767 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vermiclear	GRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUM	Energique, Inc.	f9df74a8-f225-44ca-91ba-dca4f3f35da0	2024-08-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1f4491ab-95b0-cc14-e063-6394a90a73ca	2024-08-09	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b737146d-fb50-4ed6-ab5e-6aff3393992a	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	54b07420-6a30-4481-99f5-a7d6a4df898c	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	65659277-cd30-453c-929e-3651c9f19da8	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	28ae9c39-eb79-4a19-8149-af8d8e7901ae	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	05f7119a-0c92-4393-a62d-8e84ec451d20	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b90ee1ba-17b5-4367-9df3-e9e27217960c	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ad5c5121-d75d-449d-a4db-a7b074787f68	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 00	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	0018573d-922b-4642-9513-63481e9131d5	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	83b20b0d-c2db-4720-8434-57b73847ebca	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	105651f2-3c99-4ff3-b67b-350a40dc8888	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7b1b551b-e78d-47ff-bb91-0d5f676c73fc	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2411e8e6-a958-4fd9-b5e9-b9a32020ce54	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	062f61d2-a9a7-46e1-92e4-a6bdf257c188	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	9c3d513f-8331-4155-a77b-c358093a607c	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b7f8d1d0-1734-46a5-82fe-b0ac14017522	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3C	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c3849d5c-4f91-4147-aeb2-7461a3a94309	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4C	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e8f29488-10f8-4df6-b1f5-d9a670f60fca	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	86e0d1e4-3207-49e6-b5fa-e63f4ca300db	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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