NDC 0641-6083-01 - 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: 0641-6083
Requested NDC: 0641-6083-01
Package NDCs from labels: 0641-6083-01, 0641-6083-25
Manufacturer: Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date: 2025-06-30
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
PHENERGAN - Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	2025-06-30	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
0641-6083-01	PHENERGAN	1 mL in 1 AMPULE	INJECTION	1		8
0641-6083-25	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
0641-6083	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]	7	Current NDC, Legacy NDC, 2 package rows	20240606_6f7e47cc-f823-4336-8107-f980e3049617.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6083-01	ML - Milliliter	0641-6083	dfad8183-56c1-4ff4-9a23-6f0c223deddb	1	2012-07-24
0641-6083-25	ML - Milliliter	0641-6083	8e6fb053-ab30-49c2-9207-68fef87ea2a3	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.]	2
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
PHENOL	INACTIVE INGREDIENT	339NCG44TV	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	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 26 of 28 · 560 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ChemDetox	BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM	Dr. Donna Restivo DC	2a17f80d-12c0-43a0-980b-9da648e9b76a	2023-01-10	Warnings	Exact identifier unii: 339NCG44TV
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	59b906c6-2ccc-416e-b3ee-db09bf553146	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
Multiple Electrolytes pH 7.4	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Fresenius Kabi USA, LLC	84221110-b3f1-42f4-800c-ad1d3b330e9e	2022-11-10	Warnings, Adverse reactions	Exact identifier unii: 4550K0SC9B
Multiple Electrolytes pH 5.5	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Fresenius Kabi USA, LLC	cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c	2022-11-10	Warnings, Adverse reactions	Exact identifier unii: 4550K0SC9B
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	ba7d9e82-9b13-4607-b2f9-25e575b8c73b	2022-11-05	Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
Sterile Water	WATER	Fresenius Kabi USA, LLC	b45e9f1d-9c48-4b46-8541-d846b89540df	2022-10-26	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye wash	PURIFIED WATER	McKesson	bd089fde-24ba-4de5-e053-2995a90a39bb	2022-10-18	Warnings	Exact identifier unii: 059QF0KO0R
Promethazine	PROMETHAZINE	PharmPak, Inc.	4f681538-7ac4-484c-9e6d-b571d73b9e0b	2022-10-08	Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
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
Acidum Carbolicum	ACIDUM CARBOLICUM	Hahnemann Laboratories, INC.	e3e1a345-0183-9cbe-e053-2a95a90adff0	2022-07-15		Exact identifier unii: 339NCG44TV
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
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: M4I0D6VV5M
Calcarea Muriatica	CALCAREA MURIATICA	Hahnemann Laboratories, INC.	df517477-164b-33cc-e053-2a95a90a2083	2022-05-18		Exact identifier unii: M4I0D6VV5M
Bio Co-Enzyme Phase	BETA VULGARIS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,	Deseret Biologicals, Inc.	e8f6e2ec-ae2e-4bee-b9d3-5f3a2e3daf65	2022-05-09	Warnings	Exact identifier unii: Q40Q9N063P
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION	Proficient Rx LP	68a4c521-6db0-4e94-9906-96e96e251301	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	29a8b172-1bad-40db-8d73-1fe7fb309cff	2022-04-01	Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
Miracle FootCream Lavender	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db520c80-2a2a-5eb1-e053-2995a90a5bb4	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K
Miracle FootCream Lemon	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db525c63-29fd-2033-e053-2995a90a56b9	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K

Reported adverse events (FAERS/openFDA)#

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