PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
33d6acff-2858-46b2-bb9d-37b520ff015a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 28, 2010
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 Code16590-047
Application NumberANDA040622
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROMETHAZINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 28, 2010
FDA Product Classification
INGREDIENTS (11)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 1
Code: R61ZEH7I1I
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT