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 20 of 28 · 560 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	b0d5abba-6fae-4f3c-b990-dd9c83c7b5a9	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA083312 rxcui: 992460 unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	365138a6-28d8-4881-a3e9-02c80aaf83e8	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA083312 rxcui: 992460 rxcui: 992858 unii: R61ZEH7I1I
Sterile Water	WATER	B. Braun Medical Inc.	8fc8d87a-3951-4ac5-97df-c161ffc90475	2024-04-10	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	da246971-20b8-b46e-8366-9700d3604cf1	2024-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
Eye Wash	WATER	M-star (Hubei) Health&Care Products Co., Ltd.	71706039-e250-4f08-9687-71b2928c4e46	2024-04-01	Warnings	Exact identifier unii: 059QF0KO0R
Sore Throat Cherry	PHENOL	Family Dollar (FAMILY WELLNESS)	7806fac7-736e-44b0-baa2-42feb7237417	2024-03-27	Warnings	Exact identifier unii: 339NCG44TV
ACETIC ACID	ACETIC ACID	Chartwell RX, LLC	2aaf3781-4f25-4799-8dcd-78d67e226ccc	2024-03-26	Warnings, Adverse reactions	Exact identifier unii: Q40Q9N063P
Calcium Chloride	CALCIUM CHLORIDE	American Regent, Inc.	c5ef90b3-6ef0-410c-97d7-66a130b90741	2024-03-26	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M
ULINE Eyewash	EYEWASH	Uline.	14545fc9-1fb4-befa-e063-6294a90a0474	2024-03-23	Warnings	Exact identifier unii: 059QF0KO0R
Balanced Salt	SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE	B. Braun Medical Inc.	74ab8883-0a5f-46b4-8998-9358f6fd4ef4	2024-03-13	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M unii: 4550K0SC9B
Chemtox	BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOL	Deseret Biologicals, Inc.	91f52c95-f36d-4754-8570-f81ed8d36180	2024-03-06	Warnings	Exact identifier unii: 339NCG44TV
Calcium Chloride	CALCIUM CHLORIDE	International Medication Systems, Limited	8295039b-2559-4626-90c8-6ac7e896e41a	2024-03-01	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Asclemed USA, Inc.	b4985d9d-1aa0-4b36-bc98-6a5410ad9bad	2024-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
CALCIUM CHLORIDE	CALCIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a9500f41-8041-d753-e053-2a95a90a6f3c	2024-02-26	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M
PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a	2024-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA083312 rxcui: 992858 unii: R61ZEH7I1I
PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	7447e8c6-c198-cd2d-e053-2a91aa0a3895	2024-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA083312 rxcui: 992460 unii: R61ZEH7I1I
GI Drainage	CINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOS	Deseret Biologicals, Inc.	ff81e3ca-2f88-4daf-a734-083107269d3a	2024-02-21	Warnings	Exact identifier unii: 059QF0KO0R
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	e451cb8d-f856-479f-bee9-4cccab210b1e	2024-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
Dysbio Plus	ACETICUM ACIDUM, ALOE, ARSENICUM ALBUM, BOTULINUM, BRUGIA MALAYI, CHININUM SULPHURICUM, CHOLERA NOSODE, CLOSTRIDIUM DIFFICILE, COLCHICUM AUTUMNALE, COLIBACILLINUM CUM NATRUM MURIATICUM, COLOCYNTHIS, ECHINACEA (ANGUSTIFOLIA), HELICOBACTER PYLORI, HELICOBACTER PYLORI DNA, MERCURIUS CORROSIVUS, MORGAN GAERTNER, NUX VOMICA, PROTEUS (VULGARIS), SALMONELLA TYPHI NOSODE	Deseret Biologicals, Inc.	6864ab8e-3cf9-460e-b471-84ba3fb2efe0	2024-02-07	Warnings	Exact identifier unii: Q40Q9N063P
Dysbio Plus	ECHINACEA (ANGUSTIFOLIA), ALOE, COLCHICUM AUTUMNALE, COLOCYNTHIS, MERCURIUS CORROSIVUS, NUX VOMICA, ARSENICUM ALBUM, ACETICUM ACIDUM, CHININUM SULPHURICUM, CHOLERA NOSODE, PROTEUS (VULGARIS), COLIBACILLINUM CUM NATRUM MURIATICUM, HELICOBACTER PYLORI, BOTULINUM, SALMONELLA TYPHI NOSODE, MORGAN GAERTNER, CLOSTRIDIUM DIFFICILE, BRUGIA MALAYI	Deseret Biologicals, Inc.	974f23e5-9062-42c1-9df3-12168edee141	2024-02-07	Warnings	Exact identifier unii: Q40Q9N063P

Reported adverse events (FAERS/openFDA)#

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