NDC 0641-6006-01 - Atropine Sulfate

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: 0641-6006
Requested NDC: 0641-6006-01
Package NDCs from labels: 0641-6006-01, 0641-6006-10
Manufacturer: Hikma Pharmaceuticals USA Inc.
Effective date: 2024-04-08
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Atropine Sulfate Injection, USP	Hikma Pharmaceuticals USA Inc.	2024-04-08	HUMAN PRESCRIPTION DRUG LABEL
Atropine Sulfate - Medical Purchasing Solutions, LLC	Medical Purchasing Solutions, LLC	2023-05-31	HUMAN PRESCRIPTION DRUG LABEL
Atropine Sulfate - General Injectables & Vaccines, Inc	General Injectables & Vaccines, Inc	2022-12-09	HUMAN PRESCRIPTION DRUG LABEL
Atropine Sulfate Injection, USP FOR IM, IV, OR SC USE Rx Only	Henry Schein, Inc.	2022-01-09	HUMAN PRESCRIPTION DRUG LABEL
ATROPINE SULFATE - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2020-09-04	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6006-01	Atropine Sulfate	20 mL in 1 VIAL	INJECTION	20		4
0641-6006-10	Atropine Sulfate	10 in 1 CARTON	INJECTION	10		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6006	ATROPINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	4	Legacy NDC, 2 package rows	20240410_5d45eb2f-b964-4f64-b277-eef807520466.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6006-01	ML - Milliliter	0641-6006	0dd1cebf-afb5-463c-8066-2ae1248537db	1	2012-07-24
0641-6006-10	ML - Milliliter	0641-6006	50fad021-aa7f-43ab-b295-6c10da590ef3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATROPINE SULFATE	ACTIVE INGREDIENT	03J5ZE7KA5	ATROPINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
Atropine Sulfate	ACTIVE INGREDIENT	03J5ZE7KA5	ATROPINE SULFATE INJECTION [GENERAL INJECTABLES & VACCINES, INC]	1
ATROPINE	ACTIVE MOIETY	7C0697DR9I	ATROPINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
Atropine	ACTIVE MOIETY	7C0697DR9I	ATROPINE SULFATE INJECTION [GENERAL INJECTABLES & VACCINES, INC]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ATROPINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ATROPINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	ATROPINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ATROPINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1

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 54 of 61 · 1,220 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isopto Atropine	ATROPINE SULFATE	Alcon Laboratories, Inc.	20491566-e6eb-8d4a-3083-77ea429f7bc4	2022-10-07	Warnings, Adverse reactions	Exact identifier unii: 03J5ZE7KA5
Bach Original Flower Remedies Rock Water	WATER	Nelson Bach USA Limited	ea242559-1618-3354-e053-2a95a90a1a95	2022-10-03	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Medical Purchasing Solutions, LLC	e90b47e3-9636-b9ee-e053-2a95a90ad48c	2022-09-19	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Dr Talbots Infant Daily Allergy Relief	ALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6X	Talbot's Pharmaceuticals Family Products,LLC.	e8bdcc8a-c947-ff5d-e053-2a95a90a3b92	2022-09-12	Warnings	Exact identifier unii: 451W47IQ8X
Herplex	ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA	Nashco Products LLC	6a1322c7-7767-4569-aa22-9d2e36331283	2022-08-30	Warnings	Exact identifier unii: 451W47IQ8X
Kids Cold and Cough Nighttime Grape Flavor	ONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFUR	Hyland's Consumer Health Inc.	e676dbb7-212f-47e3-e053-2995a90af4e1	2022-08-17	Warnings	Exact identifier unii: 451W47IQ8X
Kids Cold and Cough Daytime Grape Flavor	ONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFUR	Hyland's Consumer Health Inc.	e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d	2022-08-16	Warnings	Exact identifier unii: 451W47IQ8X
Bruise RX	ERIGERON CANADENSIS, HAMAMELIS VIRGINIANA, PHOSPHORUS, SULPHURICUM ACIDUM, ARNICA MONTANA, LEDUM PALUSTRE, BELLIS PERENNIS	Remedies Cure, LLC	8fbac9c7-45ac-4a9b-bdff-6f19d238a601	2022-08-10	Warnings	Exact identifier unii: O40UQP6WCF
Sterile Saline Kids Mist PediaMeds	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC.	e5c5b580-1d9f-3081-e053-2995a90a8031	2022-08-08	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Saline Kids Mist SinuCleanse Breathe	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC.	e5c5c313-046f-b0a7-e053-2a95a90a2a07	2022-08-08	Warnings	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	123bd10a-90c7-499e-97f6-acf7e0f0fb4e	2022-07-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Herplex	ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA	Nashco Products LLC	fad9615f-7004-415d-9f69-ee9ff95f0067	2022-07-12	Warnings	Exact identifier unii: 451W47IQ8X
BHI Constipation	DIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEED	MediNatura Inc	0365b75b-fee4-4c1d-89ab-c692bdd73f75	2022-07-07	Warnings	Exact identifier unii: 451W47IQ8X
Donnatal	PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE	VistaPharm, LLC	11a48ba9-576b-4e8c-9536-6e83636d6930	2022-07-07	Warnings, Adverse reactions	Exact identifier unii: 03J5ZE7KA5
Natrium Muriaticum 6X	SODIUM CHLORIDE	Seroyal USA	0ebf18de-12fe-0bc4-e054-00144ff88e88	2022-07-07	Warnings	Exact identifier unii: 451W47IQ8X
Erogetone	ARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA	Energique, Inc.	1e872ecd-e7a5-463d-9832-47b7046096db	2022-06-28	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Winder Laboratories LLC	7344a2d2-1f8a-4c5a-90e3-181b919c0c7a	2022-05-31	Warnings, Adverse reactions	Exact identifier unii: 03J5ZE7KA5
Cardioplegic Solution	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Fresenius Kabi, USA, LLC	eb360dc4-88d6-4b28-9b61-bc359e16bd22	2022-05-27	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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