NDC 0641-6085-01 - 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: 0641-6085
Requested NDC: 0641-6085-01
Package NDCs from labels: 0641-6085-01, 0641-6085-25
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
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
0641-6085-01	PHENERGAN	1 mL in 1 VIAL	INJECTION	1		8
0641-6085-25	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
0641-6085	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
0641-6085-01	ML - Milliliter	0641-6085	50f91db9-692b-4dde-87f3-182e33936af5	1	2012-07-24
0641-6085-25	ML - Milliliter	0641-6085	d4418999-3934-4bbd-9fce-9999eb58033b	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 19 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	NuCare Pharmaceuticals,Inc.	8749824b-6d66-430d-e053-2995a90a2db8	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7e5715cf-056f-4095-e053-2991aa0ad3e5	2024-06-12	Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
Eyes Alive Eye Wash	WATER	RIVIERA PHARMA INC	081079f4-1c06-4054-b771-00fedaa666f6	2024-06-05	Warnings	Exact identifier unii: 059QF0KO0R
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	4bf3912c-8339-401e-9711-dad6acf15f11	2024-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA083312 rxcui: 992460 rxcui: 992858 unii: R61ZEH7I1I
Sterile Water	WATER	Becton Dickinson and Company	6e43c5a3-dad2-49ed-b500-964cb4563cc9	2024-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Liver Drainage	CHELIDONIUM MAJUS, CARDUUS MARIANUS, SCHISANDRA CHINENSIS, TARAXACUM OFFICINALE, BERBERIS VULGARIS, RAPHANUS SATIVUS, VISCUM ALBUM, CHROMIUM PICOLINATE, COBALT GLUCONATE, COPPER GLUCONATE, MAGNESIUM GLUCONATE, NATRUM SULPHURICUM, PTELEA TRIFOLIATE, SARCOLACTICUM ACIDUM, SULPHUR IODATUM, CARBOLICUM ACIDUM, CICHORIUM INTYBUS, FLOS, GALLBLADDER (SUIS), HEPAR SUIS, NUX VOMICA, PANCREAS SUIS, VANADIUM METALLICUM, VERBENA OFFICINALIS, FLOS, PICRORHIZA KURROA	Deseret Biologicals, Inc.	1857dee7-4227-4fa3-9d70-1f0226439290	2024-05-29	Warnings	Exact identifier unii: 339NCG44TV
Liver Drainage	BERBERIS VULGARIS, CARBOLICUM ACIDUM, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHROMIUM PICOLINATE, CICHORIUM INTYBUS, FLOS, COBALT GLUCONATE, COPPER GLUCONATE, GALLBLADDER (SUIS), HEPAR SUIS, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM SULPHURICUM, NUX VOMICA, PANCREAS SUIS, PICRORHIZA KURROA, PTELEA TRIFOLIATE, RAPHANUS SATIVUS, SARCOLACTICUM ACIDUM, SCHISANDRA CHINENSIS, SULPHUR, TARAXACUM OFFICINALE, VANADIUM METALLICUM, VERBENA OFFICINALIS, FLOS, VISCUM ALBUM	Deseret Biologicals, Inc.	bd3151b4-fe34-4288-b8e0-ba8850f4b39b	2024-05-28	Warnings	Exact identifier unii: 339NCG44TV
Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE	Fresenius Kabi USA, LLC	dbed53b7-0109-4561-8342-0178ec8c64b0	2024-05-22	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M
Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	Fresenius Kabi USA, LLC	1b912c7e-f005-4af4-b683-083440964249	2024-05-22	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M
PHENERGAN	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	481866da-a712-48a5-853f-8e84aacaab6d	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA083312 ndc (package): 0641-6085-25 ndc (package): 0641-6085-01 ndc (package): 0641-6084-01 ndc (package): 0641-6084-25 ndc (product): 0641-6085 ndc (product): 0641-6084 ndc11 (package): 00641608501 rxcui: 992876 rxcui: 992460 rxcui: 992462 rxcui: 992858 spl id: 7d6e64fc-bbf2-4ea9-b866-8115c448e687 spl set id: 481866da-a712-48a5-853f-8e84aacaab6d unii: R61ZEH7I1I
GI Distress	ACETICUM ACIDUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, COLIBACILLINUM CUM NATRUM MURIATICUM, COLOCYNTHIS, CROTON TIGLIUM, ECHINACEA (ANGUSTIFOLIA), FERRUM METALLICUM, GAMBOGIA, IRIS VERSICOLOR, LAC DEFLORATUM, MERCURIUS VIVUS, NATRUM PHOSPHORICUM, NUX VOMICA, PROTEUS (MIRABILIS), RICINUS COMMUNIS, VERATRUM ALBUM	Deseret Biologicals, Inc.	40df69fa-92ae-4f26-8664-36955cf395c5	2024-05-13	Warnings	Exact identifier unii: Q40Q9N063P
GI Distress	ECHINACEA (ANGUSTIFOLIA), NATRUM PHOSPHORICUM, COLCHICUM AUTUMNALE, ARSENICUM ALBUM, COLOCYNTHIS, CROTON TIGLIUM, GAMBOGIA, ACETICUM ACIDUM, ANTIMONIUM CRUDUM, BISMUTHUM SUBNITRICUM, CINCHONA OFFICINALIS, FERRUM METALLICUM, IRIS VERSICOLOR, LAC DEFLORATUM, MERCURIUS VIVUS, NUX VOMICA, RICINUS COMMUNIS, VERATRUM ALBUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (MIRABILIS)	Deseret Biologicals, Inc.	056ac695-82d3-4164-9123-79520b5deecc	2024-05-08	Warnings	Exact identifier unii: Q40Q9N063P
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	Asclemed USA, Inc.	f4ca52c6-9f90-7bb5-e053-2a95a90ae3ff	2024-05-07	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M
Sore Throat Cherry	PHENOL	QUALITY CHOICE (Chain Drug Marketing Association)	9162ae27-ddbb-4336-9655-487995919de4	2024-05-01	Warnings	Exact identifier unii: 339NCG44TV
HPYL PLUS	ANGELICA ARCHANGELICA, GERANIUM MACULATUM, HYDRASTIS CANADENSIS, SINAPIS NIGRA, SYMPHYTUM OFFICINALE, RATANHIA, ACETICUM ACIDUM, CARBOLICUM ACIDUM, ORNITHOGALUM UMBELLATUM, ABIES CANADENSIS, ANACARDIUM ORIENTALE, BISMUTHUM SUBNITRICUM, CONDURANGO, GRAPHITES, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MEZEREUM, EUPHORBIUM OFFICINARUM, NUX VOMICA, URANIUM NITRICUM	Deseret Biologicals, Inc.	39445c53-e661-4203-a4fb-a071075ac0e2	2024-04-26	Warnings	Exact identifier unii: Q40Q9N063P unii: 339NCG44TV
LACTATED RINGERS	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Fresenius Kabi USA, LLC	7a723a23-3bc1-4f69-b82f-d06a35dc68d6	2024-04-24	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M
Glyreg	ACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCA	Deseret Biologicals, Inc	28e670ca-ed35-4256-af20-74c25dc18099	2024-04-23	Warnings	Exact identifier unii: Q40Q9N063P
PEMF Optimizer	AQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUM	Deseret Biologicals, Inc.	97d57469-4c5b-4d3f-9398-3a1a6617a649	2024-04-23	Warnings	Exact identifier unii: 059QF0KO0R
Promethazine Hydrochloride and Codeine Phosphate	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	Bryant Ranch Prepack	df2c24ba-1c88-4ec3-b2a1-801358ec645c	2024-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
Sterile Water	WATER	Hikma Pharmaceuticals USA Inc.	78ef7ad3-451d-43d0-a9b6-5cf0aadca003	2024-04-10	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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