PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE 25mg
Approved
Approval ID
2c5d4ccc-5d67-0329-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2016
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PROMETHAZINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-630
Application NumberANDA040863
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROMETHAZINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2016
FDA Product Classification
INGREDIENTS (5)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: R61ZEH7I1I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Drug Labeling Information
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 2/18/2016
ADVERSE REACTIONS
WARNINGS SECTION
LOINC: 34071-1Updated: 2/18/2016
WARNINGS
PRECAUTIONS SECTION
LOINC: 42232-9Updated: 2/18/2016
PRECAUTIONS
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 2/18/2016
OVERDOSAGE
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 2/18/2016
DOSAGE AND ADMINISTRATION
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 2/18/2016
STORAGE
PATIENT MEDICATION INFORMATION SECTION
LOINC: 68498-5Updated: 2/18/2016