FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
PHENERGAN Injection (promethazine hydrochloride Injection, USP) Rx onlyHikma Pharmaceuticals USA Inc.2024-05-20HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6085-01PHENERGAN1 mL in 1 VIALINJECTION18
0641-6085-25PHENERGAN25 in 1 CARTONINJECTION258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6085PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20240606_481866da-a712-48a5-853f-8e84aacaab6d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6085-01ML - Milliliter0641-608550f91db9-692b-4dde-87f3-182e33936af512012-07-24
0641-6085-25ML - Milliliter0641-6085d4418999-3934-4bbd-9fce-9999eb58033b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
PROMETHAZINEACTIVE MOIETYFF28EJQ494PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
PHENOLINACTIVE INGREDIENT339NCG44TVPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
WATERINACTIVE INGREDIENT059QF0KO0RPHENERGAN (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 3 of 28 · 560 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.804e2525-d61f-7bed-e053-2991aa0a5daa2026-06-30Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAdvagen Pharma Ltd8b60eff2-5759-4bc3-ac16-5ff80aa153a02026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: Q40Q9N063P
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: 339NCG44TV
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDECamber Pharmaceuticals, Inc.6a2cd2d6-6e0f-4b2d-be7a-8b99627f44532026-06-09Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
unii: 339NCG44TV
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepacke6d940f8-fa1a-4a75-b4fc-2cbbaf7a04882026-06-05Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepackf9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c472026-06-04Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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