PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE 25 MG TABLETS
Approved
Approval ID
e23c09c2-47f5-47c1-825f-cbd8e3440058
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 26, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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 Code42549-543
Application NumberANDA083426
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROMETHAZINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2012
FDA Product Classification
INGREDIENTS (6)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: R61ZEH7I1I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT