NDC 0641-6084-01 - PHENERGAN

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: 0641-6084
Requested NDC: 0641-6084-01
Package NDCs from labels: 0641-6084-01, 0641-6084-25
Manufacturer: Hikma Pharmaceuticals USA Inc.
Effective date: 2024-05-20
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
PHENERGAN Injection (promethazine hydrochloride Injection, USP) Rx only	Hikma Pharmaceuticals USA Inc.	2024-05-20	HUMAN PRESCRIPTION DRUG LABEL
PHENERGAN Injection (promethazine hydrochloride Injection, USP) Rx only	REMEDYREPACK INC.	2024-04-18	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
0641-6084-01	PHENERGAN	1 mL in 1 VIAL	INJECTION	1		8
0641-6084-25	PHENERGAN	25 in 1 CARTON	INJECTION	25		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6084	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]	8	Current NDC, Legacy NDC, 2 package rows	20240606_481866da-a712-48a5-853f-8e84aacaab6d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6084-01	ML - Milliliter	0641-6084	caa69793-2308-4973-bacb-3a17b830242d	1	2012-07-24
0641-6084-25	ML - Milliliter	0641-6084	f7054ac3-d7ee-4f24-9372-1975c7336112	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	4
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	4
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	4
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	4
PHENOL	INACTIVE INGREDIENT	339NCG44TV	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	4
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	4
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	4

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 24 of 29 · 561 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anubis Barcelona	PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOIN	ANUBIS COSMETICS SL	eb9244ea-6102-3cbe-e053-2a95a90ab8f6	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Vital Line	HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES	ANUBIS COSMETICS SL	ebe024f7-7c45-ad60-e053-2995a90a45d6	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona	PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL	ANUBIS COSMETICS SL	ebdddcec-f5da-51fe-e053-2995a90a6167	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Regul Oil	PROPYLENE GLYCOL, PANTHENOL, THIAMINE HCL	ANUBIS COSMETICS SL	eb8e5beb-4452-58c2-e053-2a95a90a66e0	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Protective Line	ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE	ANUBIS COSMETICS SL	ec83846f-11c0-8f59-e053-2995a90ab9d2	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Regul Oil	CETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE	ANUBIS COSMETICS SL	eb68c3ab-7835-1a1c-e053-2995a90a0d66	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona	PROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE	ANUBIS COSMETICS SL	eb53cba1-0509-43bc-e053-2995a90a5e09	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Spa Line	ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID	ANUBIS COSMETICS SL	eb01a962-ab38-18ec-e053-2995a90acdeb	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona	FERULIC ACID, VITAMIN C, DMAE	ANUBIS COSMETICS SL	eaf0770c-795d-0232-e053-2a95a90ae0b5	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Regul OIl	PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACT	ANUBIS COSMETICS SL	eb905bd0-c600-b8b2-e053-2995a90ad259	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Regul Oil	PROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACT	ANUBIS COSMETICS SL	eb7c418b-8bee-26a3-e053-2a95a90a4e96	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Total Hydrating	BETAINE, GLYCERIN, POLYSORBATE 20	ANUBIS COSMETICS SL	eaefe3b9-9064-18b1-e053-2a95a90a5765	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona New Even	LACTIC ACID, CITRIC ACID, GLYCOLIC ACID	ANUBIS COSMETICS SL	eaeeb6e0-5322-20c4-e053-2995a90a9fd9	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Ringers	SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	b53c598c-dc7d-4a15-9319-8edf265e7b42	2023-08-30	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M
Anubis Barcelona Vital Line	HYDROLYZED COLLAGEN	ANUBIS COSMETICS SL	f564bbf0-3b5c-4a81-e053-2a95a90a7ea6	2023-08-29	Warnings	Exact identifier unii: 059QF0KO0R
Pancreapar	SYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUM	Energique, Inc.	99a4560e-f124-4569-a2f1-78ce5995f8e0	2023-08-24	Warnings	Exact identifier unii: Q40Q9N063P
Pancreapar	SYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUM	Energique, Inc.	ba9c13d0-92de-4159-8a35-215e3de50c07	2023-08-24	Warnings	Exact identifier unii: Q40Q9N063P
Acetic Acid	ACETIC ACID	B. Braun Medical Inc.	dd45cee3-9938-4dad-a5e1-1dd4baea85a9	2023-08-23	Warnings, Adverse reactions	Exact identifier unii: Q40Q9N063P
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL	A-S Medication Solutions	9c3e0e87-b2f5-4a09-9db8-6d088d2a5f25	2023-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	ee227c52-2cd8-4a06-a2de-a257f1f4732a	2023-07-11	Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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