FDA.reportPublic FDA data

NDC 0641-6099-01 - Promethazine Hydrochloride

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
0641-6099
Requested NDC
0641-6099-01
Package NDCs from labels
0641-6099-01, 0641-6099-25
Manufacturer
West-ward Pharmaceutical Corp. | West-ward Pharmaceutical Corp
Effective date
2011-09-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROMETHAZINE - West-ward Pharmaceutical Corp. | West-ward Pharmaceutical CorpWest-ward Pharmaceutical Corp. | West-ward Pharmaceutical Corp2011-09-15HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0641-6099-252024-06-05C16284748780-1960f7f55-d58f-8e05-e053-dbdaa90a074aPromethazine Hydrochloride Injection, USP Rx only
0641-6099-252019-10-29C16284748780-1960f7f55-d58f-8e05-e053-dbdaa90a074aPromethazine Hydrochloride Injection, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6099-01ML - Milliliter0641-609944485d47-ac32-4783-97cd-c5cb391cca8d12012-07-24
0641-6099-25ML - Milliliter0641-6099c055dafe-ee66-446f-963b-9f3d22150d8a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
PHENOLINACTIVE INGREDIENT339NCG44TVPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5

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 25 of 29 · 561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tap Water DetoxACETONE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARSENICUM METALLICUM, BARYTA MURIATICA, CADMIUM METALLICUM, CARBOLICUM ACIDUM, CHLORINUM, CHROMIUM (METALLICUM), CUPRUM METALLICUM, FERRUM METALLICUM, GERMANIUM METALLICUM, NATRUM FLUORATUM, PLUMBUM METALLICUM, RADIUM BROMATUM, VANADIUM METALLICUM, GLYPHOSATE HERBICIDENutritional Specialties, Inc.37a48fea-a8df-4d27-b0c7-e5704c25e72f2023-07-11WarningsExact identifier
unii: 339NCG44TV
Aceticum acidumACETIC ACIDBoiron69214a87-0b8c-702d-e053-2a91aa0a34162023-07-03Exact identifier
unii: Q40Q9N063P
Calcium ChlorideCALCIUM CHLORIDEMedical Purchasing Solutions, LLC6685165a-0df7-0ae0-e053-2a91aa0a3f222023-05-30Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Calcium ChlorideCALCIUM CHLORIDEMedical Purchasing Solutions, LLC6b15706b-199c-beba-e053-2991aa0a17342023-05-30Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLC677b5fc5-94be-638b-e053-2991aa0a7f972023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA083312
unii: R61ZEH7I1I
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Calcium ChlorideCALCIUM CHLORIDE INJECTIONMedical Purchasing Solutions, LLC9e502cf2-3f4d-13ec-e053-2a95a90a970e2023-05-10Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutions2c9a4767-23c4-4a1c-bb4c-2bad1351c2702023-05-08Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLCdc8b50de-e4f6-607f-e053-2995a90a29022023-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA083312
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProficient Rx LPdcb1694a-8451-403c-b848-edb89ba170202023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
DysBio PlusECHINACEA (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 MALAYIDeseret Biologicals, Inc.4dcb84ac-48a4-4e09-a6ff-9748218149002023-04-20WarningsExact identifier
unii: Q40Q9N063P
HPYL PLUSANGELICA 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, URANIUM NITRICUM, EUPHORBIUM OFFICINARUM, NUX VOMICADeseret Biologicals, Inc.a13a91e0-572a-4f9c-b80e-f161f055e6fd2023-04-10WarningsExact identifier
unii: Q40Q9N063P
unii: 339NCG44TV
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLC32022e66-6f76-430a-8ad2-1e9e2872fee12023-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEQUAGEN PHARMACEUTICALS LLC9aca56ec-28f8-4679-9f90-ec3e82deb9ac2023-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions87429921-00d2-42c7-9e99-600e8075b8ce2023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsc930985b-bba3-4f3a-a1ae-1d808670efde2023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA083312
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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