LIDOCAINE HYDROCHLORIDE
Approved
Approval ID
cdbc5206-a2da-4d71-920d-4d31d6702769
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2010
Manufacturers
FDA
STAT RX LLC USA
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LIDOCAINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-140
Application NumberANDA040014
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL, TOPICAL
Effective DateSeptember 8, 2010
FDA Product Classification
INGREDIENTS (9)
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT