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 117 of 139 · 2,767 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20	TITANIUM DIOXIDE	Boscia LLC	f76166f1-e987-4eaf-8192-14dc08c481f7	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PA	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Boscia LLC	2a6b507f-0967-46e1-8360-0003772f1bdb	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
3LAB Aqua BB SPF 40 BROAD SPECTRUM 01	TITANIUM DIOXIDE	3LAB, Inc.	703dc828-24b4-4f04-9f2c-4a2edfdf4632	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
3LAB Aqua BB SPF 40 BROAD SPECTRUM 02	TITANIUM DIOXIDE	3LAB, Inc.	7c6c7062-91f7-4304-98c3-f77967a2d329	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
3LAB PERFECT BB SPF 40 Broad Spectrum 01	TITANIUM DIOXIDE	3LAB, Inc	bd39d2fb-8326-4e19-b634-7a7308313d8a	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
3LAB PERFECT BB SPF 40 Broad Spectrum 03	TITANIUM DIOXIDE	3LAB, Inc	19884289-edb2-4d18-bd62-873533b94a10	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Bass Pro Shops Mineral Sun Stick Sunscreen Broad Spec SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	92dc1a86-590e-4144-9d30-172645e63140	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
3LAB PERFECT BB SPF 40 Broad Spectrum 02	TITANIUM DIOXIDE	3LAB, Inc	bf4419b9-408d-469a-aa15-bbf419632f02	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Likewise Facial Moisturizer - Sun Protectant SPF 50 Oily Skin	TITANIUM DIOXIDE, ZINC OXIDE	Likewise Incorporated	28b8c519-8417-427e-8d4f-94da44a69d9f	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Bass Pro Shops Bass P Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	c06ecc56-2044-4396-8acd-6d18af9b984c	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	f5c7b7ce-b3ed-3e96-e053-2995a90a8ea9	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight	TITANIUM DIOXIDE	LOreal USA Products Inc	4692b146-1abe-48e8-b097-ea9c556962b6	2023-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
Vichy Laboratoires Capital Soleil 60 Mineral Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight Sunscreen	TITANIUM DIOXIDE	Cosmetique Active Production	acb887bc-7e46-4257-9fe3-a2cade6c4f38	2023-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
Erborian BB creme au Ginseng chocolate SPF 20	OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	ddcd6ea4-e7b1-88df-e053-2a95a90a9923	2023-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	43c81760-6bb6-25fe-e054-00144ff8d46c	2023-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Erborian CC Dull Correct SPF25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	cb23ba95-1e83-4523-a35c-3b70c0605dd1	2023-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Nitrofurantion	NITROFURANTION	A-S Medication Solutions	43848e61-4d94-46f7-a610-93be927c8d16	2023-12-09	Warnings, Adverse reactions	Exact identifier unii: 927AH8112L
Cetaphil Sheer Mineral Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	ac2d5713-9955-477e-a10f-e8a1191b5fdd	2023-12-07	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1720cff-a897-68cb-e053-2995a90a30b6	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12272c3-d4ed-2212-e053-2995a90add37	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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